At a Glance
- Tasks: Lead regulatory strategy across Europe and ensure compliance with EU MDR/UK MDR.
- Company: Join GE HealthCare, a leader in innovative healthcare solutions.
- Benefits: Competitive salary, comprehensive benefits, and opportunities for professional growth.
- Other info: Collaborative environment with cross-functional teams and dynamic challenges.
- Why this job: Make a significant impact on healthcare regulations and drive compliance across Europe.
- Qualifications: Proven leadership in regulatory affairs and experience in global organisations.
The predicted salary is between 80000 - 100000 £ per year.
GE HealthCare is seeking a senior Regulatory Affairs leader to drive regulatory strategy across Europe, ensuring compliance with EU MDR/UK MDR and related guidance. You will oversee submissions, Notified Bodies interactions, and regulatory due diligence while partnering with Quality, Legal, Commercial, and Product teams.
The role requires a strong track record in leadership and strategic planning in regulatory affairs, with experience in global, matrixed organizations and SaMD knowledge.
We think you need these skills to ace European Regulatory Affairs Director — Strategy & Compliance
Regulatory Strategy Development
EU MDR Compliance
UK MDR Compliance
Submissions Management
Notified Bodies Interaction
Regulatory Due Diligence
Leadership Skills
