14 Regulatory Framework jobs in Ireland

**About Abbott**
Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 114,000 colleagues serve people in more than 160 countries.
**Abbott in Ireland**
Abbott has been operating in Ireland since 1946 and serves the Irish market with a diverse range of healthcare products including diagnostics, diabetes care, medical devices and nutritional products. In Ireland, Abbott currently employs about 6,000 people across ten sites located in Dublin, Donegal, Clonmel, Cootehill, Galway, Kilkenny, Longford and Sligo.
WHAT YOU'LL DO
**Responsibilities:**
- Regulatory project management for global programs (PIERs, Global Science Innovation, Supply Network, Strategic) without close supervision by manager.
- Lead strategic programs with supervision by manager.
- Develop and execute regulatory strategies to ensure successful registration and approval of international nutrition products.
- Represent Abbott Nutrition regulatory affairs on departmental and divisional teams, providing timely regulatory input and communication to ensure regulatory requirements are met.
- Analyse and identify regulatory requirements against project needs.
- Communicate registration needs before and during product development.
- Prepare options, suggestions, and/or a regulatory assessment for product registration to achieve global project goals.
- Execute plans, complete tasks according to priorities set by Manager, align work with business goals and align actions with agreed upon strategies.
- Excellent verbal and written communication skills and ability to effectively present scientific data to management.
- Assure established policies and standard interpretations of regulations are followed for assigned projects. Maintain an awareness of legislation and assess impact on Abbott business.
- Responsible for tracking and timely completion of regulatory assignments, registration assessments, and execution of filing
- Responsible for effective communication of regulatory requirements to project teams and internal customers (scientists, marketing, quality assurance, product development, affiliates).
- Accountable for compliance with internal SOPs and understanding & compliance with relevant Regulations.
- Position is highly visible to internal and external stakeholders.
**EDUCATION AND EXPERIENCE, YOU'LL BRING**
**Required:**
- Bachelor's degree is required (engineering, nutrition, chemistry or biological science is
preferred)
- 3 or more years of relevant experience (exposure to regulatory affairs is preferred)
- Project management experience and/or exposure to project management principles.
- High level of effective verbal and written communication skills, including ability to negotiate,
influence, and manage conflict.
- Able to work constructively, decisively, and collegially with internal customers (scientists, marketing, quality assurance, product development, affiliates, etc.) to solve problems and communicate regulatory needs.
**Preferred:**
- Master's degree.
- Prior regulatory experience in the food industry.
- Knowledge of regulations relating to foods, infant formula manufacturing and/or consumer products.
- Manufacturing/Quality/Packaging or similar experience.
Connect with us at and on LinkedIn , Facebook , Instagram , X and YouTube .
An Equal Opportunity Employer
Abbot welcomes and encourages diversity in our workforce.
We provide reasonable accommodation to qualified individuals with disabilities.
To request accommodation, please call or email

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

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 1 year 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.

Regulatory Affairs Senior Specialist ABOUT XEOLAS Xeolas is an Irish-owned speciality Pharmaceutical company located in Dublin, Ireland with 70+ employees. We develop and manufactureinnovativepatient friendly pharmaceutical products for international markets. We are now seeking an experiencedRegulatory Affairs Senior Specialistas weexpand. OVERALL ROLE OBJECTIVE The Regulatory Affairs Senior Specialist will report directly to the Regulatory Affairs Manager and be involved in all aspects of regulatory affairs of the company including existing licensed products as well as products under development. SPECIFIC RESPONSIBILITIES Reporting To: Manager Regulatory Affairs REQUIREMENTS: Preparation and maintenance of high quality dossiers (marketing authorisation applications/ Response to Health authority questions/ post-approval submissions). Submission of CPP/ Manufacturing authorisation requests to HPRA/MHRA Review of data intended for submission and advise regarding any deficiencies or issues. Ensure on-time submissions for all quality/ safety related changes for assigned projects. Preparation and submission of translated texts to EU/Non-EU countries Update of databases and systems for all products (in-line with current SOPs) Liaise with 3rd parties (where required) to establish effective communication and relationships in order to progress regulatory activities. Liaise closely with Business Development, Product Launch, Artwork, Supply Chain and Quality colleagues to ensure alignment in all initiatives. Advise management of the status and progress of assigned projects identifying potential problems or delays, and possible solutions, as they occur and maintain a current status report for these projects. Maintain an awareness of regulatory requirements (including legislation, guidelines, industry best practice, and through liaison with competent Authorities) and use this information to optimise departmental procedures and processes and to ensure Health Authority requirements and Regulatory Compliance are maintained. Embrace Xeolas values and behaviour Support the Xeolas business by participating in project teams to support departmental initiatives. On an ad hoc basis, carry out additional tasks on behalf of Regulatory Affairs Manager. KEYSKILLS /EXPERIENCE REQUIREMENTS For this role, we're looking for a candidate who has an effective combination of the following qualifications, skills and experiences: Masters/ Bachelor's degree or equivalent in Science/Technology/ Pharmacy Minimum 7 years of Experience in Regulatory Capable of understanding health authority expectations for pharmaceuticals for EU/US/ROW regions. Must possess organization skills, time management skills and attention to detail. Excellent critical thinking and problem-solving abilities. Strong interpersonal and communication skills Experience in dealing with multiple stakeholders, both internal and external.

Overview

Associate Director Regulatory Affairs - Ireland, Dublin - 12 Month Contract

Are you looking for the chance to join a life changing pharmaceutical organisation in their mission to continuously drive innovation? We are recruiting for a Associate Director Regulatory Affairs to support the Dublin function.

Responsibilities

• Developing and implementing global regulatory strategies for assigned products.
• Providing regulatory strategic oversight for projects in the relevant therapeutic areas/portfolio, as assigned, aligned to overall Enterprise objectives through initial registration and subsequent lifecycle management.
• Providing input to submission strategy and other critical regulatory documents. May act as the point of contact with relevant Health Authorities and/or lead interactions with such authorities or other relevant external stakeholders.
• May provide input to internal governance and advisory bodies from which GRA staff can seek insight on strategic and procedural/operational issues as they arise.
• Actively being up to date on latest regulatory requirements and trends and contribute to the shaping of the regulatory science environment.
• Support regulatory intelligence and policy priorities based on internal knowledge and expertise.
• Ensuring exemplary behavior, leadership, ethics and transparency within the Enterprise, with Health Authorities and other external stakeholders.

Desirable experience/Qualifications

• Extensive Regulatory experience in the pharmaceutical industry, with significant track record on Global Strategies.
• Strong knowledge of drug development and regulatory policy, coupled by excellent scientific and business judgement.
• Experience providing strategic regulatory advice for the global development of products through all stages of development including marketed assets.
• Successful track record in registering and overseeing regulatory strategies for assets.
• Bachelor's Degree, life science highly desirable
• Postgraduate degrees relevant to the role (e.g. MSc, PhD) a plus

If this role is of interest, please apply now.

**Job Description Summary**
Provides regulatory strategy and direction to the business regarding healthcare industry regulatory requirements for product launch, premarket submissions/registrations and postmarket compliance, working closely with healthcare regulatory bodies globally. Interprets simple internal and external business challenges and recommends best practices to improve products, processes or services. Stays informed of industry trends that may influence work.
**Job Description**
**Roles and Responsibilities**
+ **Leadership & Strategy**
+ Lead and develop the European Regulatory Affairs team, fostering a high-performance and collaborative culture.
+ Define and execute regulatory strategies aligned with GE HealthCare's global objectives.
+ Represent Regulatory Affairs in cross-functional leadership forums and strategic initiatives.
+ **Regulatory Compliance**
+ Ensure compliance with EU MDR and other applicable European regulations.
+ Act as PRRC under MDR, ensuring product conformity and regulatory documentation integrity.
+ Oversee regulatory submissions, CE marking processes, and interactions with Notified Bodies and Competent Authorities.
+ **Operational Excellence**
+ Drive continuous improvement in regulatory processes and systems.
+ Monitor regulatory changes and assess impact on GE HealthCare's product portfolio.
+ Support audits, inspections, and regulatory due diligence activities.
+ **Stakeholder Engagement**
+ Collaborate with Quality, Legal, Commercial, and Product teams to ensure regulatory alignment.
+ Provide expert guidance and training on European regulatory requirements.
+ Represent GE HealthCare in industry associations and regulatory forums as needed.
**Required Qualifications**
+ Bachelor's or Master's degree in Life Sciences, Engineering, or related field.
+ Minimum 10 years of experience in Regulatory Affairs, with significant exposure to European medical device regulations.
+ Proven leadership experience, including team management and strategic planning.
+ Fluent in German and English (written and spoken).
+ Must be based in the European Union and meet the qualifications to act as PRRC under MDR.
+ Strong knowledge of EU MDR, IVDR, and relevant guidance documents.
+ Excellent communication, negotiation, and stakeholder management skills.
**Desired Characteristics**
+ Experience working in a global or matrixed organization.
+ Familiarity with digital health technologies and software as a medical device (SaMD).
+ Ability to influence and lead through change.
#LI-AO1
#LI-Hybrid
**Additional Information**
**Relocation Assistance Provided:** No

**12 Months maternity leave cover. (Fixed term contract)**
**Position Summary**
Under general direction, responsible for the leadership and directing of complex projects, which often require resources and functional integration. Responsibility for all aspects of the project from initiation to completion.
Interfaces with all stakeholders affected by the project, including end users.
Develop, implement and maintain compliant, harmonised, best practice market clearance / registration processes across Europe, Middle East and Africa.
Provide maturity and significant RA experience and expertise to the EMEA RAQA team to accelerate market access.
Partner with the business by driving regulatory processes and activities through strategic projects.
**What you will do:**
+ Lead the execution of EMEA registration plans for assigned franchises, ensuring high-quality regulatory dossiers and timely approvals/renewals.
+ Serve as primary contact with Stryker Design Divisions for market clearance and renewal activities, supporting ongoing market access aligned with business strategy.
+ Collaborate with RAQA management and International RA teams to develop and execute submission strategies, share best practices, and optimize product registration processes.
+ Participate in product lifecycle management planning and maintain RA execution throughout all phases of the product lifecycle.
+ Manage project scope, deliverables, resources, schedules, and budgets; monitor performance, risks, and changes to ensure timely, efficient project completion.
+ Lead, train, mentor, and motivate project teams to improve performance, enhance collaboration, and ensure project efficiency.
+ Record and communicate customer requirements, constraints, and assumptions; align stakeholders through clear expectations and project plans.
+ Analyze and monitor franchise registration activities, using appropriate tools to track performance, implement corrective actions, and support EMEA/Country RAQA teams.
**What you need**
Required
+ Bachelor's degree with an emphasis in management or related discipline or equivalent
+ 4 years + relevant experience
+ Minimum of 1- 2 years demonstrated project management experience
Preferred:
+ Project management experience in medical devices
+ PMP certification or equivalent (i.e. PRINCE2)
+ Prior divisional or site experience desired
#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.

Who are we looking for Head of Ireland Regulatory Affairs is responsible for driving the strategic relationship with the Central Bank of Ireland (CBI) by: building effective relationships with supervision teams; generating insight into the regulator's supervision strategy and its implications for State Street; providing insight into areas of focus in regulatory exams and continuous assessment meetings through briefings to senior management; providing preparation sessions for staff selected for interview as part of regulatory examinations; and ensuring that regulatory information requests are well managed with timely responses and submission of deliverables, and that State Street's regulatory interactions with the CBI are cohesive and unified, with appropriate engagement with the PCF-12 Heads of Compliance for the regulated legal entities. The role is classified as a CF2 under the Central Bank of Ireland Fitness and Probity regime (CF2), hence candidates must comply with the relevant requirements regarding fitness and probity. This role can be performed in a hybrid model, where you can balance work from home (up to 2 days per week) and the office (at least 3 days per week including Monday and Friday) to match your needs and role requirements. What you will be responsible for: As Head of Ireland Regulatory Affairs, your responsibilities entail: Regulatory Liaison: Act as the primary liaison with regulators, delivering best in class service to the CBI by ensuring all regulatory deliverables are met within the CBI's timeframes and to the appropriate quality, engaging with the PCF-12 Heads of Compliance for the regulated legal entities Assist the business in making regulatory notifications and drafting responses to CBI queries relating to issues, incidents and other matters Providing senior management and the business with insightful analysis into CBI priorities and areas of focus Internal Stakeholder Management: Strategic regulatory stakeholder management and communication Arrange all regulatory meetings ensuring appropriate attendance from State Street senior management and others, as appropriate Manage the preparation of briefing notes for forthcoming regulatory continuous assessment meetings, in conjunction with the Global Regulatory Liaison Office (GRLO), where applicable to ensure consistency of messaging on key themes and actions Lead the coordination and preparation for regulatory examinations, including deliverables requested by the CBI, and act as internal point of escalation across the Ireland business lines in such reviews/exams Attendance at regulatory meetings to provide minutes of discussions and agreed actions Assess actions received as a result of regulatory exams in accordance with the definition in the Issue Management Standard and the Regulatory Examination & Findings Standard - Global, overseeing the opening of Archer items (RMPs) and agreeing action owners Track all RMP actions from opening through governance to closure, ensuring that responses meet the standard expected by the CBI Work in conjunction with internal stakeholders such as the Regulatory Industry & Governmental Affairs to identify and shape areas of upcoming regulatory change or other policy developments Regulatory/Internal Reporting: Prepare updates for the CBI on matters requiring regulatory notification, in response to queries and to assist the regulator's understanding of State Street's business in Ireland Prepare monthly regulatory interactions update for inclusion in submissions to relevant Ireland and global governance forums, including Ireland Legal Entity Boards, attending where necessary. Contribute to the Compliance Risk Reporting to the relevant Ireland and global governance forums Prepare summaries of regulatory publications for key Ireland Governance Forums, Senior Management and other internal stakeholders Highlight regulatory enforcement actions against other market participants to ensure State Street applies any relevant learning from such industry events Contribute to Compliance newsletters in Ireland to highlight areas of regulatory focus Skills we value: Proven analytical skills including the ability to synthesize complex information and articulate it in a form that is easily digestible for leadership and others Strong writing and presentation skills stakeholder management skills, particularly the ability to engage with regulators, State Street senior management and Board Directors Education & Preferred Qualifications Degree Qualified Technical specialist in relation to the regulatory regime in Ireland and the CBI's regulatory priorities and how these affect State Street's business model and strategy; Previous experience in a Regulatory Relations role or Supervision/Enforcement (at the CBI or an equivalent regulator); Sound knowledge of the custody and / or funds sector would be an advantage. Are you the right candidate? Yes! We truly believe in the power that comes from the diverse backgrounds and experiences our employees bring with them. Although each vacancy details what we are looking for, we don't necessarily need you to fulfil all of them when applying. If you like change and innovation, seek to see the bigger picture, make data driven decisions and are a good team player, you could be a great fit. About State Street What we do. State Street is one of the largest custodian banks, asset managers and asset intelligence companies in the world. From technology to product innovation, we're making our mark on the financial services industry. For more than two centuries, we've been helping our clients safeguard and steward the investments of millions of people. We provide investment servicing, data & analytics, investment research & trading and investment management to institutional clients. Work, Live and Grow. We make all efforts to create a great work environment. Our benefits packages are competitive and comprehensive. Details vary by location, but you may expect generous medical care, insurance and savings plans, among other perks. You'll have access to flexible Work Programs to help you match your needs. And our wealth of development programs and educational support will help you reach your full potential. Inclusion, Diversity and Social Responsibility. We truly believe our employees' diverse backgrounds, experiences and perspectives are a powerful contributor to creating an inclusive environment where everyone can thrive and reach their maximum potential while adding value to both our organization and our clients. We warmly welcome candidates of diverse origin, background, ability, age, sexual orientation, gender identity and personality. Another fundamental value at State Street is active engagement with our communities around the world, both as a partner and a leader. You will have tools to help balance your professional and personal life, paid volunteer days, matching gift programs and access to employee networks that help you stay connected to what matters to you. State Street is an equal opportunity and affirmative action employer. Discover /careers 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 Continue to Application or Login/Register to apply button below.