Senior CAPA and Vigilance Manager / Medical Device Safety
Based in Frankfurt
My client is a global, market leading medical device manufacturer. Within their specialist area of active medical devices, 1 in 2 of devices worldwide are produced by them. The company is very well known, highly regarded, and offer drug device combination products up to Class III. The position is focused on medical device safety and is part of a global RA/QM division.
Working closely with different departments, you will be responsible for ensuring the safety of medical devices and maintaining CE-marking for their medical device portfolio. You'll be guiding colleagues through the process of regulatory compliance, with a specialist focus on complaint handling, vigilance systems and risk management.
- Conducting post market surveillance and carrying out required reporting to competent authorities
- The preparation and submission of authority notifications for medical device incidents and field safety corrective actions
- Define and maintain processes, indicators and tools with regards to medical device vigilance
- Collect information on product risks and document assessment criteria
- CAPA monitoring and notified body reporting
- Post market surveillance summaries
- The preparation of monthly and quarterly KPIs
- Product risk assessments
- Degree in medical, technical or scientific studies or similar
- Several years of professional experience in medical device vigilance or in RA/QM overseeing the vigilance activities (as a team lead, or senior specialist)
- Expertise with MDD & MDR
- Sound understanding of vigilance processes and organizational structures
- Strong communication skills with the ability to handle confidential information while interacting with different business functions
- German and English at a fluent level
Please apply with your CV or contact the job poster Rebecca Stevens for further details on this opportunity and additional vacancies in Regulatory Affairs and Quality Management.