Director, Regulatory Affairs, Europe (m/f/d)

Your Profile:

• 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.
  
• 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.

Your Tasks:

• 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.
  
• 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.
  
• 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.
  
• 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.

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