Director, Regulatory Affairs, Pre-Market

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.

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.

GE HealthCare is an equal opportunities employer and welcomes applications from all qualified candidates. We are committed to diversity and inclusion in the workplace.