Director, Regulatory Affairs, Europe
GE HEALTHCARE —Chalfont Saint Giles
- Engineering
- Master's degree
- Bachelor's degree
Director of Public Affairs, UK
Abbott Laboratories —Maidenhead
- Full-time
- Bachelor's degree
- Communication skills
Associate Director, Regulatory Project Manager
CSL Behring —Maidenhead
- £170,000 - £210,000 a year
- Full-time
- Doctoral degree
- PMP
- Master's degree
Vice President, Medical Affairs Rare Diseases
Recordati —Hemel Hempstead
- £245,552 - £368,358 a year
- Full-time
- Hybrid work
- Doctoral degree
- English
- Travel
- Annual leave
Global Medical Affairs Associate Director - Metabolic & Dermato-Oncology
Recordati —Hemel Hempstead
- Full-time
- Hybrid work
- English
- Travel
- In-person
5d
Marketing Sr Director and Launch Lead - Metabolic and Dermato-Oncology Franchise
Recordati —Hemel Hempstead
- Full-time
- Hybrid work
- Management
- Marketing
- English
Director Safety Surveillance & Risk Management (12 months fix term contract)
Viatris —Hatfield
- Full-time
- Hybrid work
- Bachelor's degree
- Time management
- Health & wellbeing programme
- Employee assistance programme
Associate Director Global CMC QU – Clinical GMP/GDP
Kyowa Kirin International plc —Marlow
- £80,000 - £140,000 a year
- Full-time
- Bachelor's degree
- No degree
- Leadership
Associate Director Global CMC QU – Clinical GMP/GDP
Kyowa Kirin International —Marlow
- £66,814 - £134,641 a year
- Full-time
- Bachelor's degree
- No degree
- Leadership
Quick apply
Head of Global Labelling
CSL Seqirus —Maidenhead
- Full-time
- Leadership
Director - Regulatory Platforms
CSL Behring —Maidenhead
- Full-time
- Computer Science
- Bachelor's degree
- Travel
8d
Vice President / Associate Director, Crisis & Risk
Edelman —London
- Full-time
- Project management
- IT
Senior Director, Structured Component Management (SCM) Strategy, Operations & Governance
GlaxoSmithKline —Stevenage
- Full-time
- Hybrid work
- SQL
- Bachelor's degree
- Machine learning
4d
Country Medical Director, UK and Ireland
Gilead Sciences —London
- Full-time
- Hybrid work
- Leadership
8d
Executive Director, Global Patient Safety Sciences Delivery
Regeneron —Uxbridge
- Management
- Doctoral degree
- Master's degree
- Annual leave
Water & Waste Stewardship Manager
Reckitt —Slough
- Remote
- Engineering
- Analysis skills
- Travel
- Employee assistance programme
- Life insurance
Director, Marketing
Gilead Sciences —Uxbridge
- Full-time
- Hybrid work
- AI
- Leadership
- Communication skills
Medical Advisor
Norgine —Uxbridge
- Full-time
- Hybrid work
Quick apply

I want to receive the latest job alerts for director of regulatory affairs in tring, hrt

By signing in to your account, you agree to SimplyHired's Terms of Service and consent to our Cookie and Privacy Policy.

Explore jobs in more locations

director of regulatory affairs jobs near tring, hrt

Director, Regulatory Affairs, Europe

GE HEALTHCARE -
Chalfont Saint Giles

Apply Now

Job details

Qualifications

Engineering
Master's degree
Bachelor's degree
Team management
Leadership
Communication skills
Negotiation

Full job description

Job Description Summary

This role 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

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.
Knowledge of PRRC under MDR, and UKRP under UK MDR, ensuring product conformity and regulatory documentation integrity.
Oversee regulatory submissions, CE / UKCA marking processes Importer and Distributor responsibilities, 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.
Strong knowledge of EU MDR, UK MDR, and relevant guidance documents.
EU and UK IVD regulatory expertise desirable.
Excellent communication, negotiation, and stakeholder management skills.

Preferred 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.
Strong growth mindset and proactive approach.

Inclusion and Diversity

GE HealthCare is an Equal Opportunity Employer where inclusion matters. Employment decisions are made without regard to race, color, religion, national or ethnic origin, sex, sexual orientation, gender identity or expression, age, disability, protected veteran status or other characteristics protected by law.

Behaviors

We expect all employees to live and breathe our behaviors: to act with humility and build trust; lead with transparency; deliver with focus, and drive ownership – always with unyielding integrity.

Total Rewards

Our total rewards are designed to unlock your ambition by giving you the boost and flexibility you need to turn your ideas into world-changing realities. Our salary and benefits are everything you’d expect from an organization with global strength and scale, and you’ll be surrounded by career opportunities in a culture that fosters care, collaboration and support.

Additional Information

Relocation Assistance Provided: No

Apply Now

Refine Your Search

director of regulatory affairs jobs in tring, hrt

Director, Regulatory Affairs, Europe

Director of Public Affairs, UK

Associate Director, Regulatory Project Manager

Vice President, Medical Affairs Rare Diseases

Global Medical Affairs Associate Director - Metabolic & Dermato-Oncology

Marketing Sr Director and Launch Lead - Metabolic and Dermato-Oncology Franchise

Director Safety Surveillance & Risk Management (12 months fix term contract)

Associate Director Global CMC QU – Clinical GMP/GDP

Associate Director Global CMC QU – Clinical GMP/GDP

Head of Global Labelling

Director - Regulatory Platforms

Vice President / Associate Director, Crisis & Risk

Senior Director, Structured Component Management (SCM) Strategy, Operations & Governance

Country Medical Director, UK and Ireland

Executive Director, Global Patient Safety Sciences Delivery

Water & Waste Stewardship Manager

Director, Marketing

Medical Advisor

I want to receive the latest job alerts for director of regulatory affairs in tring, hrt

Explore jobs in more locations

Job Description Summary

Job Description

Additional Information

Jobseeker tools

Employer Tools

Browse

Stay Connected