Hybrid Risk Manager – Medical Devices, ISO 14971 & MDR

Sinclair; Italia; Hybrid; EUR 50,000 - 70,000; Full time

Job summary

Sinclair is looking for a Risk Manager in Italy to oversee risk management for medical devices and aesthetic products, ensuring compliance with ISO standards. The role involves leading risk management activities, coordinating with cross-functional teams, and developing risk control measures.

The ideal candidate will have a Master's in Engineering, 2+ years of experience in the medical device industry, and strong knowledge in usability engineering.

Qualifications

• Minimum of 2 years of experience in regulated medical device industry.
• Knowledge of usability engineering or human factors engineering for medical devices.

Responsibilities

• Lead and coordinate all risk management activities according to ISO standards.
• Establish risk acceptance criteria for devices in development.
• Ensure risk management reports are prepared in a timely manner.

Skills

Knowledge of usability engineering

Risk assessment methods

Fluent in English

Education

Master's degree in Engineering or equivalent

Job description

Sinclair is looking for a Risk Manager in Italy to oversee risk management for medical devices and aesthetic products, ensuring compliance with ISO standards. The role involves leading risk management activities, coordinating with cross-functional teams, and developing risk control measures.

The ideal candidate will have a Master's in Engineering, 2+ years of experience in the medical device industry, and strong knowledge in usability engineering.