Medical Devices Risk Manager – ISO 14971 / MDR Lead

Sinclair; France; Sur place; EUR 50 000 - 70 000; Plein temps

Avantages offerts par ce poste

Competitive salary & performance bonuses

Career growth & learning opportunities

Health & wellness benefits

Fun team events & supportive culture

Healthcare

Lunch tickets

Outsourced benefits package

Résumé du poste

Sinclair in Lyon, France is seeking a Risk Manager to oversee risk management activities for medical devices and support new product development. This role involves leading risk management processes, ensuring compliance with regulations like ISO 14971 and MDR, and preparing risk management reports. The ideal candidate should have a Master's degree in Engineering or related fields, with at least 2 years of experience in the medical device sector. Benefits include a competitive salary, health and wellness programs, and opportunities for career growth.

Qualifications

• Minimum of 2 years’ experience in the regulated medical device industry.
• Knowledge of usability engineering or human factors engineering for medical devices.
• Experience with risk assessment methods.

Responsabilités

• Lead and coordinate all risk management activities according to ISO 14971.
• Plan, prepare and perform risk management for medical devices.
• Maintain close link to Human Factors / Usability Engineering.

Connaissances

Experience in the regulated medical device industry

Knowledge of usability engineering

Experience with risk assessment methods

Fluent in English

Formation

Master’s degree in Engineering, Materials, Biomaterials, Chemistry, Biochemistry, or Biology

Description du poste

Sinclair in Lyon, France is seeking a Risk Manager to oversee risk management activities for medical devices and support new product development. This role involves leading risk management processes, ensuring compliance with regulations like ISO 14971 and MDR, and preparing risk management reports. The ideal candidate should have a Master's degree in Engineering or related fields, with at least 2 years of experience in the medical device sector. Benefits include a competitive salary, health and wellness programs, and opportunities for career growth.