18 Regulatory Affairs jobs in Ireland

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

Regulatory Affairs Manager- candidate can come from Quality or Regulatory background. This is a permanent role with full Stryker benefits- bonus, pension and healthcare for employee and their family. Key Areas of Responsibility: Assesses links between global, societal and economic trends; stakeholder concerns and regulatory issues and requirements; and the implications for regulatory strategy Develops and updates global, regional and multi-country regulatory strategy, and aligns regulatory strategies to organizational strategies Provides guidance to integrate regulatory considerations into global product entry and exit strategy Identifies regulatory pathways for initial product designs and provides input to internal stakeholders Analyzes the adequacy of proposed regulatory pathways and strategy for initial product designs and recommends changes or refinements based on initial regulatory outcomes Assesses all requirements and potential obstacles for market access and distribution (federal, provincial/territorial/state, reimbursement, purchasing groups, etc.) and develops solutions to address anticipated obstacles Critically assesses the impact of changing regulations on preapproval and post approval strategies and approaches based on changing regulations Provides in-depth understanding and ability to incorporate regulatory strategies to expedite development for products intended for serious or life-threatening medical conditions or that address unmet medical needs (e.g. orphan, conditional approval, breakthrough therapy) Negotiates with regulatory authorities on complex issues throughout the product lifecycle Establishes working relationships and interfaces with multiple government and non-government organizations having an impact on market access and distribution Identifies the need for and manages the development and execution of new regulatory procedures and standard operating procedures Develops and manages programs that train stakeholders on current and new regulatory requirements to ensure organization-wide compliance Provides strategic input and technical guidance on global regulatory requirements to product development terms Evaluates risks of product and clinical safety issues during clinical phases and recommends regulatory solutions Evaluates proposed preclinical, clinical, and manufacturing changes for regulatory filing solutions and proposes plans for changes that do not require submissions Reviews and assesses proposals to regulatory authorities on regulatory paths and clinical plans Monitors implementation of regulatory strategies relative to product and clinical safety issues identified during clinical phases Provides knowledge and critical analysis of preapproval inspections, GCP inspections and clinical investigator relationships Provides regulatory guidance on strategy for proposed product claims/labeling Ensures clinical and nonclinical data are consistent with the regulatory requirements and support the proposed product claims Ensures policies and procedures are in place for appropriate internal review and approval of regulatory submissions Leads key negotiations and interactions with regulatory authorities during all stages of the development and review process Prepares cross-functional teams for interactions with regulatory authorities including panel/advisory committees Education / Work Experience: BS in a science, engineering or related Advanced degree preferred Minimum of 8 years experience People Management experience required #IJ #INDEMEA 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 is a 12 month contract with full Stryker benefits.
**What you will do:**
+ Assesses regulatory intelligence to assist in the development of local, regional, and global regulatory strategies Participates in advocacy activities of a technical and/or tactical nature
+ Evaluates the regulatory environment and contributes to providing internal advice throughout the product lifecycle (e.g., concept, development, manufacturing, marketing) to ensure product compliance
+ Anticipates regulatory obstacles and emerging issues throughout the product lifecycle and develops solutions
+ Identifies requirements and potential obstacles for market access distribution (federal, provincial/territorial state, reimbursement, purchasing groups, etc.)
+ Assists in the development of regulatory strategy and updates strategy based upon regulatory changes
+ Evaluates proposed products for regulatory classification and jurisdiction
+ Determines requirements (local, national, international) and options for regulatory submission, approval pathways, and compliance activities
+ Provides regulatory information and guidance for product development and planning throughout the product lifecycle to the regulatory groups and others within the organization
+ Compares regulatory outcomes with initial product concepts and recommends changes or refinements based on initial regulatory outcomes
+ Negotiates with regulatory authorities throughout the product lifecycle
+ Identifies the need for new regulatory procedures, SOPs, and participates in development and implementation
+ Helps train stakeholders on current and new regulatory requirements to ensure organization-wide compliance
+ Assists other departments in the development of SOPs to ensure regulatory compliance
+ Provides regulatory input and technical guidance on global regulatory requirements to product development teams
+ Advises stakeholders of regulatory requirements for quality, preclinical, and clinical data to meet applicable regulations
+ Assesses the acceptability of quality, preclinical, and clinical document for submission filing to comply with applicable regulations
+ Evaluates proposed preclinical, clinical, and manufacturing changes for regulatory filing solutions and proposes plans/strategizes (if appropriate) for changes that do not require submissions
+ Provides knowledge and guidance on preapproval inspections, GCP inspections, and clinical investigator relationships
+ Identifies, monitors, and submits applicable reports or notifications to regulatory authorities during the clinical research process
+ Provides regulatory information and guidance for proposed product claims/labeling
+ Ensures that the clinical and nonclinical data, in conjunction with regulatory strategy, are consistent with the regulatory requirements and support the proposed product claims
+ Prepares and submits electronic and paper regulatory submissions according to applicable regulatory requirements and guidelines
+ Monitors the progress of the regulatory authority review process through appropriate communications with the agency
+ Communicates and interacts with regulatory authorities before and during the development and review of a regulatory submission through appropriate communication tools
+ Works with cross-functional teams for interactions with regulatory authorities including panel meetings and advisory committees
**What you will need:**
+ BS in Engineering, Science, or related degree; or MS in Regulatory Science
+ Typically a minimum of 4 years' experience
#IJ
This role will be posted for a minimum of 3 days.
Stryker is a global leader in medical technologies and, together with its customers, is driven to make healthcare better. The company offers innovative products and services in MedSurg, Neurotechnology, Orthopaedics and Spine that help improve patient and healthcare outcomes. Alongside its customers around the world, Stryker impacts more than 150 million patients annually.
Stryker Corporation is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex, gender identity, sexual orientation, national origin, disability, or protected veteran status. Stryker is an EO employer - M/F/Veteran/Disability.

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.

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.

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

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

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.

Overview

Associate Director - Global Core Labeling (Regulatory Affairs)

Our client is a global healthcare leader with employees around the world who work to discover and bring life-changing medicines to those who need them. They are seeking a Global Labelling Lead who shall be at Associate Director level to join a growing team of Regulatory professionals within their Global Business Centre. The purpose of the Associate Director, Global Regulatory Affairs (GRA) Global Core Labeling role is to lead the development and maintenance of global labeling, including all core labeling documents related to drug, device, CMC, and carton/container components. The Associate Director ensures timely delivery of global labeling to our clients affiliates to facilitate simultaneous global submissions. Additionally, the Associate Director leads timely updates and communication of core labeling changes throughout the product lifecycle.

Primary Responsibilities Global Labeling Leadership

• Provide leadership for development of global labeling strategy to facilitate global simultaneous submissions.
• Implement "Accelerate Reach and Scale" initiatives related to global labeling strategy.
• Serve as global labeling representative for assigned products to drug development teams and affiliate regulatory business partners.

Core Labeling Development and Maintenance

• Lead the development and maintenance of core labeling i.e., Core Data Sheet (CDS), Core Device Labeling (CDL) that includes Core Carton, Core Quick Reference Information, and Core Instructions for Use, and CMC Core Labeling Content .
• Lead the preparation activities and facilitate approval of core labeling by the Global Product Labeling Committee (GPLC) and Global Labeling Council (GLC).
• Communicate initial and revised core labeling to global affiliates and provide support and consultation, as necessary.
• Lead the development and maintenance of clinical trial Instructions for Use

Labeling Process Excellence

• Optimize core labeling exception process. Manage core labeling exception requests and facilitate approval from leadership.
• Support periodic labeling assessments to assess compliance of affiliate product information with core labeling.
• Serve as subject matter expert for core labeling. Effectively resolve identified gaps and issues and help drive continuous improvement in labeling processes.
• Anticipate and resolve key technical or operational issues that can impact labeling development and timelines.
• Develop and present metrics to governance and other forums to monitor and improve the labeling exception process.

Lead/Influence/Partner

• Exemplify the Team behaviors of Include, Innovate, Accelerate, and Deliver.
• Model the innovation, leadership behaviors, and regulatory excellence attributes as described in Global Regulatory Affairs white papers.
• Participate in forums that share regulatory information across GRA components and other teams and business partners.
• Partner with Global Regulatory Lead and Device Strategy Lead to support global labeling strategy.
• Ensure timely communication of global labeling to global affiliates.
• Partner with Labeling Implementation Associates to ensure local labeling aligns with core labeling.

Minimum Qualification Requirements

• Bachelor's degree in a scientific or health sciences discipline (or equivalent experience).
• Industry-related experience in regulatory affairs and/or drug development experience for a minimum of 2 years.
• Demonstrated knowledge of the drug development process and regulatory/business strategies.
• Demonstrated ability to assess and manage risk in a highly regulatory environment.
• Demonstrated ability to lead, influence and partner cross-functionally.
• Demonstrated strong communication skills: writing, presenting, listening.
• Demonstrated effective teamwork skills; able to adapt to diverse interpersonal situations.
• Demonstrated attention to detail and organizational skills.
• Ability to learn and use new software/technology.
• Ability to manage multiple tasks simultaneously.

For further information please contact: Karen Shiel on or send CV in confidence to