Regulatory Affairs Manager

Salary/Rate:€60,000 - €75,000 DOE
Job type:Perm
Town/City:Stuttgart
Country:Germany
Business Sectors:Regulatory Affairs
Job ref:25461
Post Date:27. 09. 2024
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About the Role

Would you like to drive international approvals for a market-leading medical device company?

Are you interested in working with innovative biomaterial products?

We're searching for a Regulatory Affairs Manager for our client in the Stuttgart area!

Key Responsibilities:
  • Developing and maintaining technical documentation
  • Managing international regulatory approvals, particularly in the USA, including strategy, coordination, preparation, and submission.
  • Assisting distributors with regulatory matters
  • Handling communication with regulatory authorities
  • Conducting Post-Market Surveillance through database research, trend analysis, evaluation, and reporting
  • Investigating and reporting incidents and Field Safety Corrective Actions (FSCAs).
  • Overseeing change management and process improvements

Requirements:
  • A degree in Biomedical Engineering, Medical Technology, or a related field
  • Good experience in the regulated medical device industry (ISO 13485, ISO 14971, MDD, MDR, QSR, MDSAP)
  • Expertise in obtaining medical device approvals, particularly for the US FDA market.
  • You enjoy handling cross-functional department communication and advising on regulatory affairs topics
  •   Fluency in German and English

If you're interested in this position, please apply and/or contact Hollie Dear at Adaptive Life Science for more information.