Risk Manager

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.

Benefits:

• 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.


Dominika.Wyrwinska@adaptivelifescience.com


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