Risk Manager

Salary/Rate:65,000EUR - 75,000EUR
Job type:Perm
Town/City:Munich
Country:Germany
Business Sectors:Regulatory Affairs, Quality, R&D
Job ref:25177
Post Date:17. 05. 2024
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About the Role

Are you interested in joining a dynamic company who are innovating in the cardiovascular field?

Would you like to have a major impact on the successful market delivery of medical devices and transform treatment options for patients?

We're currently supporting a client in the medical device industry who are headquartered in Munich and are looking to strengthen their team.

Responsibilities:
  • Initiate, maintain, and update the risk management process in compliance with ISO 14971, 21 CFR820, and other relevant standards.
  • Develop, maintain, and update all documents within the risk management file, including risk management plans, FMEAs, annual reports, and more.
  • Coordinate and oversee all risk management activities with cross-functional teams..
  • Contribute to the assessment of customer feedback and risk evaluation, analysing quality issues, complaints, incidents, and proposed changes related to known and potential new risks.
  • Prepare all risk-related documents for the technical file, such as risk-benefit analyses.
  • Support and plan product Design Verification and Validation activities.
Requirements and Skills:
  • Bachelor’s degree in Engineering or a related field.
  • 3+ years of experience in risk management of medical devices in accordance with ISO 14971, ideally for class II or III devices.
  • Proficiency in technical, regulatory, and medical writing, with experience in drafting technical reports. 
  • Fluency in English, German is a bonus.
  • Experience working with regulatory bodies and competent authorities.
  • Basic understanding of regulatory requirements for medical devices, particularly MDR and 21 CFR820.
If you're interested in this position, please apply here and/or contact Hollie Dear at Adaptive Life Science for more information.

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