13 International Financial Regulations jobs in Ireland
Regulatory Affairs Manager
Posted 5 days ago
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Senior Specialist Regulatory Affairs

Posted 3 days ago
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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
Sr Mgr Regulatory Affairs
Posted 1 day ago
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Director of Regulatory Affairs
Posted 2 days ago
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Senior Regulatory Affairs Specialist
Posted 2 days ago
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Regulatory Affairs Senior Specialist
Posted 5 days ago
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Associate Director Regulatory Affairs
Posted 6 days ago
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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.
- 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.
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Director, Regulatory Affairs, Pre-Market

Posted 3 days ago
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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
Regulatory Affairs Project Manager EMEA (Fixed term contract)

Posted 3 days ago
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**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.
Head of Ireland Regulatory Affairs, Vice President, Hybrid
Posted today
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