GE HealthCare
Director, Regulatory Affairs, Europe
Chalfont St Giles
Posted 1 day ago
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Regulatory Strategy Lead – European Medical Device Regulatory Affairs
This role provides regulatory strategy and direction to the business regarding:
- Healthcare industry regulatory requirements for product launch, premarket submissions/registrations, and postmarket compliance.
- Global collaboration with healthcare regulatory bodies.
- Interpretation of business challenges and recommendation of best practices to enhance products, processes, or services.
- Staying informed about industry trends influencing regulatory work.
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.
- Demonstrate expertise in PRRC (Post-Re.authorisation Review报道) under MDR and UKRP (UK Regulatory Procedures) under UK MDR.
- Maintain product conformity and regulatory documentation integrity.
- Oversee:
- Regulatory submissions
- CE / UKCA marking processes
- Importer and Distributor responsibilities
- Interactions with Notified Bodies and Competent Authorities
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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 align on regulatory needs.
- Provide expert guidance and training on European regulatory requirements.
- Represent GE HealthCare in industry associations and regulatory forums.
Requirements
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 (In Vitro Diagnostics) regulatory expertise is desirable.
Skills
- Excellent communication, negotiation, and stakeholder management skills.
- Ability to influence and lead through change.
- Strong growth mindset and proactive approach.
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Preferred Characteristics
- Experience working in a global or matrixed organisation.
- Familiarity with digital health technologies and software as a medical device (SaMD).
- Alignment with commitment to Inclusion and Diversity.
Our Beehaviors
At GE HealthCare, we value:
- Acting with humility and trust-building.
- Transparency in leadership.
- Focused delivery and ownership, always with unyielding integrity.
Total Rewards
Our total rewards provide flexibility and career opportunities, supporting your growth while aligning with global strengths at GE HealthCare. Benefits include:
- Competitive salary, benefits, and growth potential.
- Career opportunities within an inclusive, supportive culture.
About GE HealthCare
We partner with customers to achieve healthcare’s greatest potential through:
- Innovative medical technology.
- Intelligent devices and care solutions.
- A culture shaped by the purpose to create a world where healthcare has no limits.
Additional Information
- Relocation Assistance Provided: No
- Primary focus on Europe-based regulatory leadership for GE HealthCare’s medical device portfolio.
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Skills
Regulatory Strategy
EU MDR Compliance
UK MDR Compliance
Team Leadership
CE Marking
UKCA Marking
Stakeholder Management
Regulatory Submissions
Notified Body Interaction
Strategic Planning
Risk Management
Medical Device Regulations
IVD Regulatory Expertise
SaMD
Digital Health Technologies
Audit Support