Full-Time Product Assessor - Medical Devices

We are seeking a detail-oriented Product Assessor for medical devices. You'll review technical files against EU Medical Device Directives/Regulations for Class I/IIa/IIb/III devices.

Responsibilities include:

• Conducting technical file reviews.
• Supporting CE marking activities.
• Ensuring reviews comply with requirements.
• Supporting colleague training.
• Adhering to SGS policies and procedures.
• Communicating with team and clients.
• Minimizing risks related to device certification.
• Ensuring regulatory compliance.
• Conducting product assessments (desk-based, occasional on-site).
• Maintaining personal competence and development.
• Managing projects as needed.
• Assisting with assessment queries.
• Meeting individual and team KPIs.
• Providing high-level service.
• Adhering to the Company's Code of Integrity & Professional Conduct.
• Prioritizing safety and health for self, colleagues and clients.

Education: Bachelor's degree in relevant field (Engineering, Medicine, Pharmacy, IT).

Experience: 4+ years healthcare product experience, with 2 years in device design/manufacturing/testing.

Required Knowledge:

• Active medical device knowledge (stand-alone software, monitoring devices, surgical, wound care devices, etc.)
• Knowledge of EN 60601, EN 62304, EN 62366, and related standards.
• Understanding of MDA/MDN/MDS codes (COMMISSION IMPLEMENTING REGULATION (EU) 2017/2185).
• Understanding of clinical application and cybersecurity.
• Experience with European Medical Device Directive (93/42/EEC) and Regulation (EU) 2017/745.
• Knowledge of relevant EU harmonized medical device standards.
• Knowledge of EMDN.
• Strong communication and written English skills.

What is the last date for applying to the job?

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