20 Regulatory Framework jobs in Ireland
Regulatory Affairs Specialist
Galway, Connacht
Medtronic
Posted 1 day ago
Job Viewed
Job Description
At Medtronic you can begin a life-long career of exploration and innovation, while helping champion healthcare access and equity for all. You'll lead with purpose, breaking down barriers to innovation in a more connected, compassionate world.
**A Day in the Life**
**Medtronic**
At Medtronic, we value what makes you unique. Be part of a company that thinks differently to solve problems, make progress, and deliver meaningful innovations.
**Our Purpose**
At our Regulatory Affairs department in Medtronic, plc, based in Galway our mission is to develop innovative strategies for regulatory approval, anticipate and respond to changing regulatory requirements, and provide strategic leadership to influence the global regulatory environment to benefit the patients we serve. Regulatory Affairs is a key function within the business and this role is supporting the Structural Heart (SH) business.
**_Come for a job, stay for a career!_**
**A Day in The Life Of:**
+ Directs or performs coordination and preparation of document packages for regulatory submissions.
+ Teams with other Regulatory Affairs Specialists and international regulatory specialists to provide regulatory support for changes to existing products.
+ Work with engineers and technical experts to develop robust regulatory strategies and resolve questions from regulatory agencies.
+ Leads or compiles all materials required in submissions, license renewal and annual registrations.
+ Supports change control activities to support global approval and implementation of product and process changes.
+ Recommends changes for labelling, manufacturing, marketing, and clinical protocol/evaluation reports for regulatory compliance.
+ Keeps abreast of regulatory procedures and changes. Develop internal procedures to ensure continuous compliance with all regulatory requirements.
+ May direct interaction with regulatory agencies on defined matters.
+ Support regulatory compliance activities, including manufacturing site registration & GMP audits as needed.
+ Monitors and improves tracking/control systems.
+ Identifies and develops best practices within the Regulatory Affairs Department including continuous development initiatives.
**Key Skills & Experience**
+ We are looking for a person qualified to Level 8 Science or Engineering honours bachelor's degree and minimum of 2 years of relevant experience.
+ Regulatory Affairs qualification is desirable, but not mandatory.
+ Regulatory experience in Medical Devices and/or Pharmaceuticals is required.
+ You are a dynamic team player and can work effectively and proactively on activities both individually and in teams.
+ You have strong technical knowledge. You are skilled in thinking critically and making sound decisions.
+ You collaborate with others and create alignment with team members.
+ You set high standards and drive accountability in the execution of your responsibilities, and you model ethical behaviour.
+ Ability to work independently and under general direction only.
+ Strong proficiency skills with I.T systems and data collection.
**Medtronic offer a competitive salary and flexible Benefits Package**
**#IJ**
**Physical Job Requirements**
The above statements are intended to describe the general nature and level of work being performed by employees assigned to this position, but they are not an exhaustive list of all the required responsibilities and skills of this position.
**Benefits & Compensation**
**Medtronic offers a competitive Salary and flexible Benefits Package**
A commitment to our employees lives at the core of our values. We recognize their contributions. They share in the success they help to create. We offer a wide range of benefits, resources, and competitive compensation plans designed to support you at every career and life stage.
This position is eligible for a short-term incentive called the Medtronic Incentive Plan (MIP).
**About Medtronic**
We lead global healthcare technology and boldly attack the most challenging health problems facing humanity by searching out and finding solutions.
Our Mission - to alleviate pain, restore health, and extend life - unites a global team of 95,000+ passionate people.
We are engineers at heart- putting ambitious ideas to work to generate real solutions for real people. From the R&D lab, to the factory floor, to the conference room, every one of us experiments, creates, builds, improves and solves. We have the talent, diverse perspectives, and guts to engineer the extraordinary.
Learn more about our business, mission, and our commitment to diversity here ( lead global healthcare technology and boldly attack the most challenging health problems facing humanity by searching out and finding solutions.
Our Mission - to alleviate pain, restore health, and extend life - unites a global team of 95,000+ passionate people.
We are engineers at heart- putting ambitious ideas to work to generate real solutions for real people. From the R&D lab, to the factory floor, to the conference room, every one of us experiments, creates, builds, improves and solves. We have the talent, diverse perspectives, and guts to engineer the extraordinary.
**We change lives** . Each team member, each day, helps to improve and redefine how the world treats the most pressing health conditions, from heart disease to diabetes. Our industry leadership comes from the passion and ingenuity of our people. That's who we are. Working alongside one another, we use science, medicine, and a profound understanding of the human body to build extraordinary technologies that can transform lives.
**We build extraordinary solutions as one team** . With one Medtronic Mindset defining how we work. Speed and decisiveness run through our DNA. Diverse perspectives inspire our bold answers to any challenge that comes our way. And we deliver results the right way, breakthrough after patient breakthrough.
**This life-changing career is yours to engineer** . By bringing your ambitious ideas, unique perspective and contributions, you will.
+ **Build** a better future, amplifying your impact on the causes that matter to you and the world
+ **Grow** a career reflective of your passion and abilities
+ **Connect** to a dynamic and inclusive culture that welcomes the challenge of life-long learning
These commitments set our team apart from the rest:
**Experiences that put people first** . Respect for people is the hallmark of our humanity. It fuels our team to positively impact even a single life. And it means we put our people first at Medtronic as well, creating a culture of belonging and always pushing to get you the career-building resources you need.
**Life-transforming technologies** . No matter your role, you contribute to technologies that transform lives. What we build empowers patients to live life on their terms.
**Better outcomes for our world** . Here, it's about more than the bottom line. Our Mission to improve human welfare drives us. We advance healthcare, society, and equity with every design, inside and outside our walls.
**Insight-driven care** . Fresh viewpoints. Cutting-edge AI, data, and automation. You're shaping the future of healthcare technology and defining the next generation of breakthroughs in care
It is the policy of Medtronic to provide equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by federal, state or local law. In addition, Medtronic will provide reasonable accommodations for qualified individuals with disabilities.
For sales reps and other patient facing field employees, going into a healthcare setting is considered an essential function of the job and we expect our employees to comply with all credentialing requirements at the hospitals or clinics they support.
This employer participates in the federal E-Verify program to confirm the identity and employment authorization of all newly hired employees. For further information about the E-Verify program, please click here ( .
For updates on job applications, please go to the candidate login page and sign in to check your application status.
If you need assistance completing your application please email
To request removal of your personal information from our systems please email
**A Day in the Life**
**Medtronic**
At Medtronic, we value what makes you unique. Be part of a company that thinks differently to solve problems, make progress, and deliver meaningful innovations.
**Our Purpose**
At our Regulatory Affairs department in Medtronic, plc, based in Galway our mission is to develop innovative strategies for regulatory approval, anticipate and respond to changing regulatory requirements, and provide strategic leadership to influence the global regulatory environment to benefit the patients we serve. Regulatory Affairs is a key function within the business and this role is supporting the Structural Heart (SH) business.
**_Come for a job, stay for a career!_**
**A Day in The Life Of:**
+ Directs or performs coordination and preparation of document packages for regulatory submissions.
+ Teams with other Regulatory Affairs Specialists and international regulatory specialists to provide regulatory support for changes to existing products.
+ Work with engineers and technical experts to develop robust regulatory strategies and resolve questions from regulatory agencies.
+ Leads or compiles all materials required in submissions, license renewal and annual registrations.
+ Supports change control activities to support global approval and implementation of product and process changes.
+ Recommends changes for labelling, manufacturing, marketing, and clinical protocol/evaluation reports for regulatory compliance.
+ Keeps abreast of regulatory procedures and changes. Develop internal procedures to ensure continuous compliance with all regulatory requirements.
+ May direct interaction with regulatory agencies on defined matters.
+ Support regulatory compliance activities, including manufacturing site registration & GMP audits as needed.
+ Monitors and improves tracking/control systems.
+ Identifies and develops best practices within the Regulatory Affairs Department including continuous development initiatives.
**Key Skills & Experience**
+ We are looking for a person qualified to Level 8 Science or Engineering honours bachelor's degree and minimum of 2 years of relevant experience.
+ Regulatory Affairs qualification is desirable, but not mandatory.
+ Regulatory experience in Medical Devices and/or Pharmaceuticals is required.
+ You are a dynamic team player and can work effectively and proactively on activities both individually and in teams.
+ You have strong technical knowledge. You are skilled in thinking critically and making sound decisions.
+ You collaborate with others and create alignment with team members.
+ You set high standards and drive accountability in the execution of your responsibilities, and you model ethical behaviour.
+ Ability to work independently and under general direction only.
+ Strong proficiency skills with I.T systems and data collection.
**Medtronic offer a competitive salary and flexible Benefits Package**
**#IJ**
**Physical Job Requirements**
The above statements are intended to describe the general nature and level of work being performed by employees assigned to this position, but they are not an exhaustive list of all the required responsibilities and skills of this position.
**Benefits & Compensation**
**Medtronic offers a competitive Salary and flexible Benefits Package**
A commitment to our employees lives at the core of our values. We recognize their contributions. They share in the success they help to create. We offer a wide range of benefits, resources, and competitive compensation plans designed to support you at every career and life stage.
This position is eligible for a short-term incentive called the Medtronic Incentive Plan (MIP).
**About Medtronic**
We lead global healthcare technology and boldly attack the most challenging health problems facing humanity by searching out and finding solutions.
Our Mission - to alleviate pain, restore health, and extend life - unites a global team of 95,000+ passionate people.
We are engineers at heart- putting ambitious ideas to work to generate real solutions for real people. From the R&D lab, to the factory floor, to the conference room, every one of us experiments, creates, builds, improves and solves. We have the talent, diverse perspectives, and guts to engineer the extraordinary.
Learn more about our business, mission, and our commitment to diversity here ( lead global healthcare technology and boldly attack the most challenging health problems facing humanity by searching out and finding solutions.
Our Mission - to alleviate pain, restore health, and extend life - unites a global team of 95,000+ passionate people.
We are engineers at heart- putting ambitious ideas to work to generate real solutions for real people. From the R&D lab, to the factory floor, to the conference room, every one of us experiments, creates, builds, improves and solves. We have the talent, diverse perspectives, and guts to engineer the extraordinary.
**We change lives** . Each team member, each day, helps to improve and redefine how the world treats the most pressing health conditions, from heart disease to diabetes. Our industry leadership comes from the passion and ingenuity of our people. That's who we are. Working alongside one another, we use science, medicine, and a profound understanding of the human body to build extraordinary technologies that can transform lives.
**We build extraordinary solutions as one team** . With one Medtronic Mindset defining how we work. Speed and decisiveness run through our DNA. Diverse perspectives inspire our bold answers to any challenge that comes our way. And we deliver results the right way, breakthrough after patient breakthrough.
**This life-changing career is yours to engineer** . By bringing your ambitious ideas, unique perspective and contributions, you will.
+ **Build** a better future, amplifying your impact on the causes that matter to you and the world
+ **Grow** a career reflective of your passion and abilities
+ **Connect** to a dynamic and inclusive culture that welcomes the challenge of life-long learning
These commitments set our team apart from the rest:
**Experiences that put people first** . Respect for people is the hallmark of our humanity. It fuels our team to positively impact even a single life. And it means we put our people first at Medtronic as well, creating a culture of belonging and always pushing to get you the career-building resources you need.
**Life-transforming technologies** . No matter your role, you contribute to technologies that transform lives. What we build empowers patients to live life on their terms.
**Better outcomes for our world** . Here, it's about more than the bottom line. Our Mission to improve human welfare drives us. We advance healthcare, society, and equity with every design, inside and outside our walls.
**Insight-driven care** . Fresh viewpoints. Cutting-edge AI, data, and automation. You're shaping the future of healthcare technology and defining the next generation of breakthroughs in care
It is the policy of Medtronic to provide equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by federal, state or local law. In addition, Medtronic will provide reasonable accommodations for qualified individuals with disabilities.
For sales reps and other patient facing field employees, going into a healthcare setting is considered an essential function of the job and we expect our employees to comply with all credentialing requirements at the hospitals or clinics they support.
This employer participates in the federal E-Verify program to confirm the identity and employment authorization of all newly hired employees. For further information about the E-Verify program, please click here ( .
For updates on job applications, please go to the candidate login page and sign in to check your application status.
If you need assistance completing your application please email
To request removal of your personal information from our systems please email
This advertiser has chosen not to accept applicants from your region.
0
Regulatory Affairs Specialist
Galway, Connacht
Medtronic Vascular Galway UC
Posted 2 days ago
Job Viewed
Job Description
At Medtronic you can begin a life-long career of exploration and innovation, while helping champion healthcare access and equity for all. You'll lead with purpose, breaking down barriers to innovation in a more connected, compassionate world. A Day in the Life Medtronic At Medtronic, we value what makes you unique. Be part of a company that thinks differently to solve problems, make progress, and deliver meaningful innovations. Our Purpose At our Regulatory Affairs department in Medtronic, plc, based in Galway our mission is to develop innovative strategies for regulatory approval, anticipate and respond to changing regulatory requirements, and provide strategic leadership to influence the global regulatory environment to benefit the patients we serve. Regulatory Affairs is a key function within the business and this role is supporting the Structural Heart (SH) business. Come for a job, stay for a career! A Day in The Life Of: Directs or performs coordination and preparation of document packages for regulatory submissions. Teams with other Regulatory Affairs Specialists and international regulatory specialists to provide regulatory support for changes to existing products. Work with engineers and technical experts to develop robust regulatory strategies and resolve questions from regulatory agencies. Leads or compiles all materials required in submissions, license renewal and annual registrations. Supports change control activities to support global approval and implementation of product and process changes. Recommends changes for labelling, manufacturing, marketing, and clinical protocol/evaluation reports for regulatory compliance. Keeps abreast of regulatory procedures and changes. Develop internal procedures to ensure continuous compliance with all regulatory requirements. May direct interaction with regulatory agencies on defined matters. Support regulatory compliance activities, including manufacturing site registration & GMP audits as needed. Monitors and improves tracking/control systems. Identifies and develops best practices within the Regulatory Affairs Department including continuous development initiatives. Key Skills & Experience We are looking for a person qualified to Level 8 Science or Engineering honours bachelor's degree and minimum of 2 years of relevant experience. Regulatory Affairs qualification is desirable, but not mandatory. Regulatory experience in Medical Devices and/or Pharmaceuticals is required. You are a dynamic team player and can work effectively and proactively on activities both individually and in teams. You have strong technical knowledge. You are skilled in thinking critically and making sound decisions. You collaborate with others and create alignment with team members. You set high standards and drive accountability in the execution of your responsibilities, and you model ethical behaviour. Ability to work independently and under general direction only. Strong proficiency skills with I.T systems and data collection. Medtronic offer a competitive salary and flexible Benefits Package #IJ Physical Job Requirements The above statements are intended to describe the general nature and level of work being performed by employees assigned to this position, but they are not an exhaustive list of all the required responsibilities and skills of this position. Benefits & Compensation Medtronic offers a competitive Salary and flexible Benefits Package A commitment to our employees lives at the core of our values. We recognize their contributions. They share in the success they help to create. We offer a wide range of benefits, resources, and competitive compensation plans designed to support you at every career and life stage. This position is eligible for a short-term incentive called the Medtronic Incentive Plan (MIP). About Medtronic We lead global healthcare technology and boldly attack the most challenging health problems facing humanity by searching out and finding solutions. Our Mission - to alleviate pain, restore health, and extend life - unites a global team of 95,000+ passionate people. We are engineers at heart- putting ambitious ideas to work to generate real solutions for real people. From the R&D lab, to the factory floor, to the conference room, every one of us experiments, creates, builds, improves and solves. We have the talent, diverse perspectives, and guts to engineer the extraordinary. Learn more about our business, mission, and our commitment to diversity here To be considered for this role you will be redirected to and must complete the application process on our careers page. To start the process click the Apply button below to Login/Register.
This advertiser has chosen not to accept applicants from your region.
1
Regulatory Affairs Manager
Galway, Connacht
Life Science Recruitment Ltd
Posted 17 days ago
Job Viewed
Job Description
Regulatory Affairs Manager Our client a fast-growing medical device company based in the West of Ireland, dedicated to transforming outcomes for patients are seeking a highly motivated Regulatory Affairs Manager to lead and oversee all regulatory compliance activities. This critical leadership role will define and execute regulatory strategies in support of both new product development and post-market activities. Role/Responsibilities Lead the regulatory strategy for new product introductions and support existing products through their full lifecycle. Manage regulatory submissions (e.g. 510(k), CE Mark) and global product registrations. Act as the primary contact for regulatory agencies, including authorities in the U.S. and Europe. Monitor and interpret evolving regulatory requirements and apply them to ensure company compliance. Partner with Quality Assurance to ensure post-market surveillance and vigilance activities meet applicable standards. Review and approve promotional and advertising materials from a regulatory perspective. Identify and allocate internal and external resources needed to maintain a robust regulatory function. Provide strategic advice and cross-functional support on all regulatory matters. Candidate Requirements Bachelors degree in Engineering, Life Sciences, or a health-related field. 10+ years of experience in the medical device industry, with a minimum of 3 years in a leadership or management role. In-depth knowledge of US FDA and EU medical device regulations (including MDR). Proven ability to handle complex regulatory submissions and interactions. Excellent organizational, leadership, and communication skills. A self-starter with a hands-on approach and the ability to thrive in a dynamic, entrepreneurial environment. Previous experience in an SME or medtech startup is highly desirable. For further information please contact James Cassidy or call in confidence
This advertiser has chosen not to accept applicants from your region.
2
Regulatory affairs manager
Galway, Connacht
Life Science Recruitment Ltd
Posted 1 day ago
Job Viewed
Job Description
Regulatory Affairs Manager Our client a fast-growing medical device company based in the West of Ireland, dedicated to transforming outcomes for patients are seeking a highly motivated Regulatory Affairs Manager to lead and oversee all regulatory compliance activities.
This critical leadership role will define and execute regulatory strategies in support of both new product development and post-market activities.
Role/Responsibilities Lead the regulatory strategy for new product introductions and support existing products through their full lifecycle.
Manage regulatory submissions (e.g.
510(k), CE Mark) and global product registrations.
Act as the primary contact for regulatory agencies, including authorities in the U.
S.
and Europe.
Monitor and interpret evolving regulatory requirements and apply them to ensure company compliance.
Partner with Quality Assurance to ensure post-market surveillance and vigilance activities meet applicable standards.
Review and approve promotional and advertising materials from a regulatory perspective.
Identify and allocate internal and external resources needed to maintain a robust regulatory function.
Provide strategic advice and cross-functional support on all regulatory matters.
Candidate Requirements Bachelors degree in Engineering, Life Sciences, or a health-related field.
10+ years of experience in the medical device industry, with a minimum of 3 years in a leadership or management role.
In-depth knowledge of US FDA and EU medical device regulations (including MDR).
Proven ability to handle complex regulatory submissions and interactions.
Excellent organizational, leadership, and communication skills.
A self-starter with a hands-on approach and the ability to thrive in a dynamic, entrepreneurial environment.
Previous experience in an SME or medtech startup is highly desirable.
For further information please contact James Cassidy or call in confidence
This critical leadership role will define and execute regulatory strategies in support of both new product development and post-market activities.
Role/Responsibilities Lead the regulatory strategy for new product introductions and support existing products through their full lifecycle.
Manage regulatory submissions (e.g.
510(k), CE Mark) and global product registrations.
Act as the primary contact for regulatory agencies, including authorities in the U.
S.
and Europe.
Monitor and interpret evolving regulatory requirements and apply them to ensure company compliance.
Partner with Quality Assurance to ensure post-market surveillance and vigilance activities meet applicable standards.
Review and approve promotional and advertising materials from a regulatory perspective.
Identify and allocate internal and external resources needed to maintain a robust regulatory function.
Provide strategic advice and cross-functional support on all regulatory matters.
Candidate Requirements Bachelors degree in Engineering, Life Sciences, or a health-related field.
10+ years of experience in the medical device industry, with a minimum of 3 years in a leadership or management role.
In-depth knowledge of US FDA and EU medical device regulations (including MDR).
Proven ability to handle complex regulatory submissions and interactions.
Excellent organizational, leadership, and communication skills.
A self-starter with a hands-on approach and the ability to thrive in a dynamic, entrepreneurial environment.
Previous experience in an SME or medtech startup is highly desirable.
For further information please contact James Cassidy or call in confidence
This advertiser has chosen not to accept applicants from your region.
3
Senior Regulatory Affairs Specialist
Dunboyne, Leinster
Amicus Recruitment
Posted 13 days ago
Job Viewed
Job Description
Join a Dynamic Regulatory Team in the Plant Protection Industry! The Client: For over thirty years, our client, an Irish-owned family firm, has been a trusted supplier of plant protection products. They are keen on making sure their customers have a good experience all round, building proper long-lasting relationships, and keeping them coming back for more through good old-fashioned loyalty. At the heart of what they do, you'll find integrity, respect, honesty, and accountability. As they keep going from strength to strength, they are looking to bolster their Regulatory team and need a bright spark for this key Senior Regulatory Affairs Executive role. They are quite flexible, offering remote or hybrid options depending on where you're based in Ireland, the UK, or across Europe. The Opportunity: Reporting straight to the Regulatory Affairs Manager, this is a proper strategic role where you can really make your mark and help shape the clients regulatory future. As Senior Regulatory Affairs Executive, you'll be key in getting regulatory applications sorted and submitted in important EU markets. This role gives the right person an opportunity to get stuck in with a supportive team, have a real say in decisions, and help work out regulatory strategy. To do well here, you'll need to be a good communicator, able to build and keep up strong relationships with the Regulatory Authorities, external consultants, and Contract Research Organisations (CROs). You'll be representing the client in a professional manner. Top-notch project management and the ability to juggle a few things at once are a must to make sure regulatory targets are hit on time. What You'll Bring to the Table: A minimum of 2 years under your belt in regulatory affairs gained in a generic R&D company, consultancy, or CRO. Familiarity with Article 34 of EU Regulation 1107/2009 in crop protection product (PPP) dossiers. Excellent written and spoken English, able to explain complicated stuff clearly and concisely. A team player through and through, with a knack for working well with others. A can-do, solution-focused attitude with a real drive to get things done. Great organisational skills and a keen eye for detail. The ability to build and maintain strong, productive relationships with all sorts of people. Bonus Points If You Have: Knowledge of the crop protection industry, including the technical side, commercial bits, farming methods, and specific crop issues. Fluency in another major European language. What's in it for You: A competitive salary that reflects your experience. The flexibility of working remotely or a mix of home and office, depending on where you are. The chance to work for a sound and growing Irish-owned company with a good reputation. A real opportunity to get involved in important decisions and help shape our regulatory approach. A supportive and friendly team where your contributions are valued. Chances to grow and develop your career in the regulatory field. Contact Caitriona Breaw @ Amicus for more information.
This advertiser has chosen not to accept applicants from your region.
4
Sr Mgr Regulatory Affairs
Dublin, Leinster
Regeneron Ireland DAC
Posted 9 days ago
Job Viewed
Job Description
At Regeneron, we're advancing science and medicine to improve lives. We're seeking a talented Regulatory Affairs Manager to join our team and play a pivotal role in supporting EU regulatory activities for oncology drug development. This is your chance to contribute to groundbreaking clinical development programs while collaborating with global experts and building relationships across the EU regulatory network. Join us in shaping the future of oncology treatments and making a meaningful impact on patients' lives. A Typical Day: As a Regulatory Affairs Manager, your day might include: Developing regulatory strategies for oncology programs by researching guidelines, EU precedents, and emerging trends. Managing CTA submissions via CTIS for multiple EU member states, ensuring compliance with EU requirements. Organizing, preparing, and reviewing CTA amendments, annual reports, and other regulatory documents. Performing critical analyses of clinical and preclinical data to develop interpretations and conclusions. Leading EU Scientific Advice requests and coordinating EMA and EU national agency meetings. Monitoring newly published EU Commission and EMA guidelines to ensure compliance and provide training for scientific staff. Representing Regeneron Regulatory Affairs in engagements with EMA scientific committees, EU national agencies, and industry associations. This Role May Be For You If: You are someone who: Thrives in a collaborative environment and enjoys working with multidisciplinary teams. Has a proven ability to navigate EU regulatory frameworks and requirements. Is detail-oriented and skilled in analyzing clinical and preclinical data. Has experience leading regulatory agency meetings and negotiating effectively with stakeholders. Is passionate about contributing to oncology drug development programs. Values continuous learning and stays updated on emerging regulatory trends. Has excellent written and verbal communication skills. To Be Considered: We're looking for candidates with: An advanced degree in a scientific discipline. At least 4 years of regulatory experience, with a focus on clinical development. Proven experience supporting EU Clinical Trial Applications through approval and study start-up. Familiarity with EMA processes such as scientific advice, orphan designation, and PIPs. Experience in oncology regulatory strategy is an advantage. A strong ability to negotiate and express clear positions to stakeholders at all levels. Preferred qualifications include experience with marketing authorization applications or life-cycle management of approved products in the centralized procedure. Why Join Us? At Regeneron, we believe in fostering innovation, collaboration, and growth. You'll have the opportunity to work with a passionate team dedicated to advancing science and improving patient outcomes. Together, we'll make a difference. Does this sound like you? Apply now to take your first step towards living the Regeneron Way. We have an inclusive and diverse culture that provides comprehensive benefits, which often include (depending on location) health and wellness programs, fitness centers, equity awards, annual bonuses, and paid time off for eligible employees at all levels. Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or parental status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. The Company will also provide reasonable accommodation to the known disabilities or chronic illnesses of an otherwise qualified applicant for employment, unless the accommodation would impose undue hardship on the operation of the Company's business. For roles in which the hired candidate will be working in the U.S., the salary ranges provided are shown in accordance with U.S. law and apply to U. positions. For roles which will be based in Japan and/or Canada, the salary ranges are shown in accordance with the applicable local law and currency. If you are outside the U.S, Japan or Canada, please speak with your recruiter about salaries and benefits in your location. Please note that certain background checks will form part of the recruitment process. Background checks will be conducted in accordance with the law of the country where the position is based, including the type of background checks conducted. The purpose of carrying out such checks is for Regeneron to verify certain information regarding a candidate prior to the commencement of employment such as identity, right to work, educational qualifications etc.
This advertiser has chosen not to accept applicants from your region.
5
Director of Regulatory Affairs
Galway, Connacht
Life Science Recruitment Ltd
Posted 12 days ago
Job Viewed
Job Description
Director of Regulatory Affairs Medical Device Start-Up Galway About the Company Our client is an ambitious, well-funded medical device start-up based in Galway, entering a critical phase of operational expansion. Backed by a proven management team with a strong track record in the start-up sector, the company is primed for significant growth both domestically and internationally. The Opportunity We are seeking a Director of Regulatory Affairs with a strong strategic vision and leadership capability to join the executive team. This is a key role where you will define and lead the companys global regulatory strategy, ensuring successful approvals and market access as the business scales rapidly. Key Responsibilities Develop and drive global regulatory strategies to support product development, commercialization, and market expansion activities. Manage all regulatory submissions (CE marking, FDA 510(k)/PMA, and other global submissions) and ensure alignment with commercial and operational timelines. Serve as the primary liaison with regulatory authorities, representing the company in all regulatory interactions and negotiations. Build and lead a high-performing regulatory team to support both early-stage product development and later-stage market access activities. Monitor and interpret evolving regulatory requirements to ensure proactive compliance across multiple geographies. Collaborate closely with cross-functional teams including R&D, Quality, Clinical, and Commercial to integrate regulatory requirements into project plans and strategic decision-making. Support due diligence and partnership activities through regulatory assessments and strategy development. About You Minimum of 10 years experience in Regulatory Affairs within the medical device industry, with at least 3 years in a leadership role. Proven success in preparing and leading regulatory submissions for Class II/III devices (EU MDR and FDA pathways essential). Strong understanding of the global regulatory environment, including emerging markets. Ability to think strategically while executing detailed regulatory plans. Exceptional leadership, communication, and stakeholder management skills. Comfortable operating in a fast-paced, high-growth, entrepreneurial environment. Degree in Life Sciences, Engineering, Regulatory Affairs, or a related technical field; Regulatory Affairs Certification (RAC) is advantageous. Whats on Offer The chance to be a key architect of the companys regulatory success during an exciting growth phase. A senior leadership role with real influence across the business. Competitive salary, equity participation, and an attractive benefits package. An entrepreneurial, high-energy culture with a leadership team known for successful start-up growth and exits. If interested in discussing further please contact James Cassidy or call in confidence
This advertiser has chosen not to accept applicants from your region.
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6
Sr mgr regulatory affairs
Dublin, Leinster
Regeneron Ireland DAC
Posted 1 day ago
Job Viewed
Job Description
At Regeneron, we're advancing science and medicine to improve lives. We're seeking a talented Regulatory Affairs Manager to join our team and play a pivotal role in supporting EU regulatory activities for oncology drug development. This is your chance to contribute to groundbreaking clinical development programs while collaborating with global experts and building relationships across the EU regulatory network. Join us in shaping the future of oncology treatments and making a meaningful impact on patients' lives. A Typical Day: As a Regulatory Affairs Manager, your day might include: Developing regulatory strategies for oncology programs by researching guidelines, EU precedents, and emerging trends. Managing CTA submissions via CTIS for multiple EU member states, ensuring compliance with EU requirements. Organizing, preparing, and reviewing CTA amendments, annual reports, and other regulatory documents. Performing critical analyses of clinical and preclinical data to develop interpretations and conclusions. Leading EU Scientific Advice requests and coordinating EMA and EU national agency meetings. Monitoring newly published EU Commission and EMA guidelines to ensure compliance and provide training for scientific staff. Representing Regeneron Regulatory Affairs in engagements with EMA scientific committees, EU national agencies, and industry associations. This Role May Be For You If: You are someone who: Thrives in a collaborative environment and enjoys working with multidisciplinary teams. Has a proven ability to navigate EU regulatory frameworks and requirements. Is detail-oriented and skilled in analyzing clinical and preclinical data. Has experience leading regulatory agency meetings and negotiating effectively with stakeholders. Is passionate about contributing to oncology drug development programs. Values continuous learning and stays updated on emerging regulatory trends. Has excellent written and verbal communication skills. To Be Considered: We're looking for candidates with: An advanced degree in a scientific discipline. At least 4 years of regulatory experience, with a focus on clinical development. Proven experience supporting EU Clinical Trial Applications through approval and study start-up. Familiarity with EMA processes such as scientific advice, orphan designation, and PIPs. Experience in oncology regulatory strategy is an advantage. A strong ability to negotiate and express clear positions to stakeholders at all levels. Preferred qualifications include experience with marketing authorization applications or life-cycle management of approved products in the centralized procedure. Why Join Us? At Regeneron, we believe in fostering innovation, collaboration, and growth. You'll have the opportunity to work with a passionate team dedicated to advancing science and improving patient outcomes. Together, we'll make a difference. Does this sound like you? Apply now to take your first step towards living the Regeneron Way! We have an inclusive and diverse culture that provides comprehensive benefits, which often include (depending on location) health and wellness programs, fitness centers, equity awards, annual bonuses, and paid time off for eligible employees at all levels! Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or parental status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. The Company will also provide reasonable accommodation to the known disabilities or chronic illnesses of an otherwise qualified applicant for employment, unless the accommodation would impose undue hardship on the operation of the Company's business. For roles in which the hired candidate will be working in the U. S., the salary ranges provided are shown in accordance with U. S. law and apply to U. positions. For roles which will be based in Japan and/or Canada, the salary ranges are shown in accordance with the applicable local law and currency. If you are outside the U. S, Japan or Canada, please speak with your recruiter about salaries and benefits in your location. Please note that certain background checks will form part of the recruitment process. Background checks will be conducted in accordance with the law of the country where the position is based, including the type of background checks conducted. The purpose of carrying out such checks is for Regeneron to verify certain information regarding a candidate prior to the commencement of employment such as identity, right to work, educational qualifications etc.
This advertiser has chosen not to accept applicants from your region.
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Director of regulatory affairs
Galway, Connacht
Life Science Recruitment Ltd
Posted 1 day ago
Job Viewed
Job Description
Director of Regulatory Affairs Medical Device Start-Up Galway About the Company Our client is an ambitious, well-funded medical device start-up based in Galway, entering a critical phase of operational expansion. Backed by a proven management team with a strong track record in the start-up sector, the company is primed for significant growth both domestically and internationally. The Opportunity We are seeking a Director of Regulatory Affairs with a strong strategic vision and leadership capability to join the executive team. This is a key role where you will define and lead the companys global regulatory strategy, ensuring successful approvals and market access as the business scales rapidly. Key Responsibilities Develop and drive global regulatory strategies to support product development, commercialization, and market expansion activities. Manage all regulatory submissions (CE marking, FDA 510(k)/PMA, and other global submissions) and ensure alignment with commercial and operational timelines. Serve as the primary liaison with regulatory authorities, representing the company in all regulatory interactions and negotiations. Build and lead a high-performing regulatory team to support both early-stage product development and later-stage market access activities. Monitor and interpret evolving regulatory requirements to ensure proactive compliance across multiple geographies. Collaborate closely with cross-functional teams including R&D, Quality, Clinical, and Commercial to integrate regulatory requirements into project plans and strategic decision-making. Support due diligence and partnership activities through regulatory assessments and strategy development. About You Minimum of 10 years experience in Regulatory Affairs within the medical device industry, with at least 3 years in a leadership role. Proven success in preparing and leading regulatory submissions for Class II/III devices (EU MDR and FDA pathways essential). Strong understanding of the global regulatory environment, including emerging markets. Ability to think strategically while executing detailed regulatory plans. Exceptional leadership, communication, and stakeholder management skills. Comfortable operating in a fast-paced, high-growth, entrepreneurial environment. Degree in Life Sciences, Engineering, Regulatory Affairs, or a related technical field; Regulatory Affairs Certification (RAC) is advantageous. Whats on Offer The chance to be a key architect of the companys regulatory success during an exciting growth phase. A senior leadership role with real influence across the business. Competitive salary, equity participation, and an attractive benefits package. An entrepreneurial, high-energy culture with a leadership team known for successful start-up growth and exits. If interested in discussing further please contact James Cassidy or call in confidence
This advertiser has chosen not to accept applicants from your region.
8
Senior regulatory affairs specialist
Meath, Leinster
Amicus Recruitment
Posted 1 day ago
Job Viewed
Job Description
Senior Regulatory Affairs Officer Pharmaceuticals (Hybrid) Location: Offices based near Dunboyne, Co.
Meath, Ireland Our client, a thriving Irish pharmaceutical group, is experiencing significant growth with market-leading OTC and Prescription medicinesacross numerous EU countries, Australia, and New Zealand.
Due to their continued expansion, they are seeking a highly motivated and experienced Senior Regulatory Affairs Officerto join their growing team.
This new position reports into the Regulatory Affairs Manager and offers a fantastic opportunity to make a tangible impact within a dynamic, family-run business that prioritises performance and offers excellent career progression.
What You'll Do: As a Senior Regulatory Affairs Officer, you'll play a crucial role in ensuring the company's diverse product portfolio complies with global regulatory frameworks.
This is a hands-on role where you'll be expected to get stuck in and drive results.
Your key responsibilities will include: Ensuring the companys products comply with all relevant regulations and standards.
Demonstrating knowledge and execution of Type IA, IB, and II Variations.
Managinglicence transfersin various international territories.
Reviewing promotional material for medicinal products.
Preparing Module 1 documentationfor National Applications.
Preparing for and participating in meetings with Regulatory Authorities.
Dealing with regulatory aspects of internationalising products and applying for reclassification.
Training and mentoring more junior team members on Regulatory processes and compliance requirements.
Monitoring and interpreting regulatory trends and changes relevant to the industry, keeping the company appraised of these.
What You'll Bring: Our client is looking for a resilient and adaptable individual with a strong sense of ownership and a proven track record in regulatory affairs.
Essential Experience & Knowledge: 3-4 years of progressive experiencein Regulatory Affairs within the pharmaceutical industry (human health).
Demonstrable experience with pharmaceutical products, specifically OTC and/or prescription medicines, with a focus on preparing and submitting dossiers for multiple EU countries.
Exceptional attention to detail and outstanding organisational skills.
Capability to work on your own initiative and take responsibility for your course of action.
Whats On Offer: Competitive Salary: A highly competitive salary, negotiable based on your experience.
Performance-Based Bonuses: Your hard work and contributions will be recognised and rewarded through performance-based bonuses.
Hybrid Working: The company embraces a hybrid working model, requiring you in their offices near Dunboyne, Co.
Meaththree days a week,with flexibility for remote work 2 days per week.
They also offer flexible start and finish times around their contracted 9-5 hours to help avoid peak traffic.
Career Progression: With a turnover of 250 million and ambitious growth plans, the opportunities for professional development and career advancement within the company are significant.
If you're a seasoned Regulatory Affairs professional looking for a challenging yet rewarding role within a rapidly expanding pharmaceutical group, we encourage you to apply!
Meath, Ireland Our client, a thriving Irish pharmaceutical group, is experiencing significant growth with market-leading OTC and Prescription medicinesacross numerous EU countries, Australia, and New Zealand.
Due to their continued expansion, they are seeking a highly motivated and experienced Senior Regulatory Affairs Officerto join their growing team.
This new position reports into the Regulatory Affairs Manager and offers a fantastic opportunity to make a tangible impact within a dynamic, family-run business that prioritises performance and offers excellent career progression.
What You'll Do: As a Senior Regulatory Affairs Officer, you'll play a crucial role in ensuring the company's diverse product portfolio complies with global regulatory frameworks.
This is a hands-on role where you'll be expected to get stuck in and drive results.
Your key responsibilities will include: Ensuring the companys products comply with all relevant regulations and standards.
Demonstrating knowledge and execution of Type IA, IB, and II Variations.
Managinglicence transfersin various international territories.
Reviewing promotional material for medicinal products.
Preparing Module 1 documentationfor National Applications.
Preparing for and participating in meetings with Regulatory Authorities.
Dealing with regulatory aspects of internationalising products and applying for reclassification.
Training and mentoring more junior team members on Regulatory processes and compliance requirements.
Monitoring and interpreting regulatory trends and changes relevant to the industry, keeping the company appraised of these.
What You'll Bring: Our client is looking for a resilient and adaptable individual with a strong sense of ownership and a proven track record in regulatory affairs.
Essential Experience & Knowledge: 3-4 years of progressive experiencein Regulatory Affairs within the pharmaceutical industry (human health).
Demonstrable experience with pharmaceutical products, specifically OTC and/or prescription medicines, with a focus on preparing and submitting dossiers for multiple EU countries.
Exceptional attention to detail and outstanding organisational skills.
Capability to work on your own initiative and take responsibility for your course of action.
Whats On Offer: Competitive Salary: A highly competitive salary, negotiable based on your experience.
Performance-Based Bonuses: Your hard work and contributions will be recognised and rewarded through performance-based bonuses.
Hybrid Working: The company embraces a hybrid working model, requiring you in their offices near Dunboyne, Co.
Meaththree days a week,with flexibility for remote work 2 days per week.
They also offer flexible start and finish times around their contracted 9-5 hours to help avoid peak traffic.
Career Progression: With a turnover of 250 million and ambitious growth plans, the opportunities for professional development and career advancement within the company are significant.
If you're a seasoned Regulatory Affairs professional looking for a challenging yet rewarding role within a rapidly expanding pharmaceutical group, we encourage you to apply!
This advertiser has chosen not to accept applicants from your region.
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