13 Regulatory Affairs jobs in Ireland

Regulatory Affairs Administrator The Company: My client is the leading global developer and manufacturer of quality control material and software for clinical laboratories based in Ballina, Co Tipperary on the Clare/Tipperary border. We are sourcing a Regulatory Affairs Administratorjoin their Teamon a contract basis, this role is ideal for someone who is looking to progress their career in Regulatory Affairs sector. Working in a small team environment you will be responsible for some of the following duties : General administrative skills in an engineering office setting, provides administrative support to regulatory staff for filing & tracking of documents. Responds to regulatory staff requests for administrative support as needed. Sets up and maintain files, prepares reports, takes minutes during team meetings. performs data entry, proofreads, and compiles special reports. Receives and distributes incoming mailing and coordinates outgoing mail, including courier services Manages the regulatory admin inbox together with other Administrative Associates. Schedules meetings and meeting arrangements. Provides meeting support as needed Communicates with both internal and external personnel as required. Prepares and maintains documentation, plans, reports, schedules, databases, spreadsheets, logs, etc. to support functions. Supports regulatory staff with submissions to regulatory authorities. Performs other duties as assigned. Qualifications: Minimum of degree qualification in relevant Science, Engineering or Quality Assurance discipline 1+ years experience working in a Quality Assurance regulated medical product environment is an advantage Thorough knowledge of FDA 21CFR820, ISO 13485, IVDD98/79/EC and international regulatory requirements Strong interpersonal skills and the ability to communicate well both verbally and in writing. Excellent attention to detail and ability to prioritise. How to Apply: If you're interested in applying, or want to know more about this job 1st, contact Sarah Jeanne in CPL Limerick on or email your Cv to in complete confidence. #Limerick25 Skills: 'Regulatory Affairs' Administrator 'Documentation Control'

Group Regulatory Affairs Manager Pharmaceuticals (Hybrid) Location: Offices based near Dunboyne, Co. Meath, Ireland Our client is a thriving Irish pharmaceutical group experiencing significant growth. Through consistent organic expansion and strategic acquisitions they have built a strong portfolio of market-leading OTC and Prescription medicines. Their products are marketed across numerous EU countries, Australia, and New Zealand. Due to their continued expansion, they are seeking a highly motivated and experienced Group Regulatory Affairs Manager to join their growing team. This is 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 the Group Regulatory Affairs Manager, you'll play a crucial role in ensuring the clients diverse product portfolio complies with global regulatory frameworks. This is a hands-on management position where you'll be expected to get stuck in and drive results. Your key responsibilities will include: Developing and implementing robust regulatory strategies to support product development and lifecycle management, particularly for our expanding portfolio acquired through acquisitions. Leading and mentoring a team of Regulatory Affairs Officers, fostering a collaborative and high-performing environment. Efficiently integrating all new portfolio acquisitions across multiple international markets. Spearheading projects to identify and resolve gaps in regulatory dossiers. Leading high-level meetings with Regulatory Authorities. Driving the regulatory aspects of internationalizing products and pursuing reclassification when appropriate. Proactively monitoring and interpreting global regulatory trends and changes, ensuring the company is always ahead of the curve. Collaborating cross-functionally with our Quality and Commercial/Marketing teams to achieve overarching company objectives. 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: 8-10 years of progressive experience in Regulatory Affairs within the pharmaceutical industry (human health). Strong knowledge of global regulatory frameworks, including MRP, DCP, and CP procedures. Demonstrable experience with pharmaceutical products, specifically OTC and/or prescription medicines, with a focus on preparing and submitting dossiers for multiple EU countries. A proactive, "roll up your sleeves" attitude with a strong drive to see tasks through to conclusion. Exceptional attention to detail and outstanding organisational skills. Ability to work autonomously, take initiative, and assume responsibility for your actions. Highly Desirable: Knowledge of medical device regulations. Experience with cosmetics regulations. Whats On Offer: Competitive Salary: A highly competitive salary, negotiable based on your experience. For a manager-level role like this. Performance-Based Bonuses: Your hard work and contributions will be recognized and rewarded through performance-based bonuses. Hybrid Working: Our client embraces a hybrid working model to offer flexibility while fostering team collaboration. You'll be required in their offices near Dunboyne, Co. Meath three days a week.They offerflexible 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! Benefits: Performance Bonus

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
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.

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-leadingOTC and Prescription medicinesacross numerous EU countries, Australia, and New Zealand. Due to their continued expansion, they are seeking a highly motivated and experiencedSenior 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 ofType IA, IB, and II Variations. Managinglicence transfersin various international territories. Reviewing promotional material for medicinal products. PreparingModule 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, specificallyOTC 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!

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.

Wondering what's within Beckman Coulter Diagnostics? Take a closer look.
At first glance, you'll see that for more than 80 years we've been dedicated to advancing and optimizing the laboratory to move science and healthcare forward. Join a team where you can be heard, be supported, and always be yourself. We're building a culture that celebrates backgrounds, experiences, and perspectives of all our associates. Look again and you'll see we are invested in you, providing the opportunity to build a meaningful career, be creative, and try new things with the support you need to be successful.
Beckman Coulter Diagnostics is proud to work alongside a community of six fellow Diagnostics Companies at Danaher. Together, we're working at the pace of change to improve patient lives with diagnostic tools that address the world's biggest health challenges.
The Regulatory Affairs Specialist for Beckman Coulter Diagnostics is responsible for ensuring that the quality systems aspects such as CAPA management, global procedure review and participation in the cross-site Global Regulatory Affairs initiatives in addition to product registration, IVDR document maintenance and minor/moderate design change management for the AU Chemistry Product line.
This position is part of the Quality and Regulatory Affairs Department located in Beckman Coulter Ireland Inc., Lismeehan, O'Callaghan's Mills, Co. Clare, Ireland and is an on-site position. At Beckman Coulter, our vision is to relentlessly reimagine healthcare, one diagnosis at a time.
You will be a part of the Regulatory Affairs team and report to the Senior Regulatory Affairs Manager, be responsible for providing regulatory support to local regulatory team on site, Beckman Coulter customers and Beckman Coulter's commercial regulatory teams globally. If you thrive in a fast paced, challenging and supporting role in a company that is focused on sustainability and want to work to build a world-class Quality and Regulatory Affairs organization-read on.
This role is eligible for flexible work arrangements
In this role, you will have the opportunity to:
+ Prepare and maintain technical files in compliance with IVD Directive and IVD regulation as applicable for the EU.
+ Act as RA representative on Design Change projects which includes the development and implementation of registration strategies for new product launches.
+ Review, preparation and compilation of documentation required for global regulatory submissions.
+ Support change management and perform RA support for minor and moderate design changes for the AU product line.
+ Support Global RA tasks/projects, which may include supporting RA colleagues outside of the Co. Clare site
+ Control distribution of product from regulatory perspective through regulatory stop ship program.
+ Be able to work in a busy environment
The essential requirements of the job include:
+ Qualified to a minimum of B.Sc. Level in a Science related field with a minimum of 3 years' experience in a QA or RA role within a manufacturing facility.
+ Excellent written and communication skills
It would be a plus if you also possess previous experience in:
+ Manage change effectively in order to better serve internal customers, external customers and legislative demands, in a busy environment, with demonstrated ability to multi-task
+ Understanding of the ISO13485, ISO9001, CMDR, MDLW, ANVISA, TGA, IVDD, IVDR and FDA (including China) regulation requirements.
At Beckman Coulter Diagnostics we believe in designing a better, more sustainable workforce. We recognize the benefits of flexible, remote working arrangements for eligible roles and are committed to providing enriching careers, no matter the work arrangement. This position is eligible for a remote work arrangement in which you can work remotely from your home. Additional information about this remote work arrangement will be provided by your interview team. Explore the flexibility and challenge that working for Beckman Coulter Diagnostics can provide.
Join our winning team today. Together, we'll accelerate the real-life impact of tomorrow's science and technology. We partner with customers across the globe to help them solve their most complex challenges, architecting solutions that bring the power of science to life.
For more information, visit .