Global Regulatory Affairs Manager at GSK responsible for developing and executing global regulatory strategies. Collaborate with cross - functional teams to ensure compliance and successful submissions.
About the role
- Lead European pre-market regulatory affairs and PRRC for GE HealthCare. Oversee MDR compliance, CE marking, submissions, Notified Body interactions.
Responsibilities
- Provide regulatory strategy and direction for pre-market product launches and registrations
- Lead and develop the European Regulatory Affairs team and define regulatory strategies aligned with global objectives
- 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
- Monitor regulatory changes and assess impact on product portfolio
- Support audits, inspections, and regulatory due diligence activities
- Collaborate with Quality, Legal, Commercial, and Product teams and represent Regulatory Affairs in cross-functional leadership forums
- Provide expert guidance and training on European regulatory requirements
- Drive continuous improvement in regulatory processes and systems
Requirements
- 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
- Experience working in a global or matrixed organization (desired)
- Familiarity with digital health technologies and software as a medical device (SaMD) (desired)
- Ability to influence and lead through change (desired)
Job title
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Not specified
Degree requirement
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