Director, Regulatory Affairs, Pre-Market

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.

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