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 regulatory bodies globally. It interprets internal and external business challenges and recommends best practices to improve products, processes, or services. The role stays informed of industry trends that may influence 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.
- 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 act with humility and build trust; lead with transparency; deliver with focus, and drive ownership – always with unyielding integrity.
Relocation Assistance
Relocation Assistance Provided: No
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