As a Regulatory Affairs Manager (m/f/d) you'll take ownership of all Regulatory topics in a very critical role to the company's future and help to fulfil relevant national and international regulatory requirements. A great opportunity to join a leading Medical Device company in Germany with a great portfolio of products .
Responsibilities
RA support during the whole product life cycle (development, certification / registration/ marketing material/post market surveillance)
Establish and update processes in your area of responsibility for staying in compliance in a changing regulatory environment, including environmental regulations (Reach, RoHS…)
Lead/support communication (registration/reporting) with authorities/regulatory agencies/designated bodies (EU and worldwide) and manage international audit/inspection programs as required
Coordinate, manage and implement regulatory strategies for new and established products
Lead/support efforts to register and launch new products
Lead/support post market surveillance activities from a regulatory perspective
Lead/support CAPA activities from a regulatory perspective
Mentor/coach/advise on IVD/MD related processes within the organisation
Supporting NRTL certification, Factory Inspection
Does this sound interesting to you?
Qualifications
Diplom/ Master's degree in medical technologies, engineering, natural sciences
Optional: Advanced training, additional qualifications
- Market Surveillance (PMS & Vigilance)
- Usability and Software Life Cycle processes
- conformity assessment of IVD/MD products, registrations in key markets (CE, US, China)
Minimum 5 years of experience in Quality and/or Regulatory Affairs for medical products or related areas with comprehensive knowledge of regulations for IVDs, (instruments, software, reagents), focus: CE-countries, US
Knowledge in Post-Market-Surveillance Activities of IVD / medical devices
Knowledge of ISO 14971 Risk Assessment Activities and Risk Management of medical devices
Basic Experience with IEC/EN 62304 and IEC/EN 62366
Basic Knowledge of IEC/EN 61010 (preferred) or IEC/EN 6060
- Fluent in English and German
