Risk Manager

Salary/Rate:60,000EUR - 80,000EUR
Job type:Perm
Business Sectors:Regulatory Affairs, Quality, R&D
Job ref:24831
Post Date:05. 01. 2024

About the Role

Risk Manager

Location:  Frankfurt area (high degree of remote flexibility)

Would you like to work for a global leader in the treatment of renal disease and support the safety of the product through a risk management process?

We are currently supporting our client who is looking for a Risk Manager to join their Product Development Team.

Your tasks:
  • Plan and execute the risk management process.
  • Create risk assessments for complaints and support the preparation of FMEAs.
  • Support the audit of design & development and risk management sessions.
  • Create and monitor the design control metrics in development, post-market activities, and change management.
  • Monitor the state of the art to continuously improve product safety.
  • Responsible for pre-production defect management (Anomaly Reports), risk analysis, and specification of countermeasures.

Your profile:
  • A degree in engineering, biology, medical technology, or equivalent.
  • Minimum of 3 years of experience in Regulatory Affairs, Research and Development, or Risk Management.
  • Experienced in medical device regulations (EU MDR, MDSAP, MDD 93/42/EEC, etc.)
  • High degree of knowledge in FMEA method, and quality management and risk management standards (ISO 13485 and ISO 14971).
  • Fluent in written and spoken English and advantage of German skills.

  • Very international environment.
  • High home office flexibility and flexible working hours.
  • Continuous support in the development.
  • Pension scheme.

 Please apply with your CV or contact Dominika Wyrwinska for further details on this opportunity and additional vacancies in Medical Technology.