Product Risk Manager

Prepare and keep updated he risk analysis for medical devices in compliance with relevant standards and guidelines

• Create and/or update of the Risk Management File
• Match the risk analysis with the usability files
• Create risk assessments for complaints
• Monitor state of the art for continuous improvement of product safety. Keeps abreast of changes to regulations and applicable standards as they bear on risk management process and risk management file
• Participates in regulatory inspection and notified body audits as risk management subject matter
• Drive continuous improvement efforts, through facilitating, leading, and collaborating with cross-function teams.
• Create and monitor the compliance metrics

Planning and execution of risk management activities throughout the product development cycle to ensure product safety.

Responsible for the specification of countermeasures (e. g. Requirements Management)

Perform activities in partnership with functional engineering groups, quality, regulatory, clinical, and R&D.

Theoretical and practical skills

• Higher education in biomedical, electrical, mechanical, software or other technical or scientific engineering.
• Experience of minimum 3 years risk management for medical devices or pharmaceuticals.
• Advanced knowledge of medical device regulations (MDR 745/2017, MDSAP etc.).
• Advanced knowledge of applicable quality management and of risk management standards (e. g. ISO13485, ISO14971, ICH Q10, EU GMP, FDA 21 CDR §820.250).
• Knowledge of FMEA methodology and of functional and constructive safety concepts.
• Fluent in English (written and spoken).