Senior Product Assessor - Active Devices

About SGS 🏢

We are SGS – the world's leading testing, inspection, and certification company. We're recognized as the global benchmark for sustainability, quality, and integrity. Our 99,600 employees operate a network of 2,600 offices and laboratories, working together to enable a better, safer, and more interconnected world.

The Role 💼

Are you a seasoned Product Assessor within an EU notified body, experienced in MDD/MDR technical documentation review? Then this exciting opportunity as a Senior Product Assessor - Active Devices at SGS is for you! You'll make a significant impact in certification, leading and mentoring a team.

What You'll Do 🎯

• Guide and support a team of Product Assessors.
• Conduct thorough technical documentation reviews, ensuring compliance with EU regulations and standards.
• Collaborate with cross-functional teams to boost efficiency and quality.
• Monitor team technical competence, KPIs, and well-being, providing feedback and support.
• Manage recruitment (CV review, interviews, onboarding).
• Develop and deliver training internally and externally.
• Address technical and sales queries in the Active Medical Devices field.
• Ensure top-tier service delivery across the SGS medical device certification network.

What You'll Need 💪

• Proven experience as a Product Assessor/Specialist/Technical File Reviewer within a Notified Body for active devices, conducting reviews against MDD and/or MDR.
• Four years of professional experience in healthcare products (design, manufacturing, auditing, or research), with two years specifically in the design, manufacture, testing, or use of assessed devices or related scientific aspects.
• Active Medical Devices knowledge (monitoring, therapeutic devices, radiation-using devices, stand-alone software, etc.) through design, manufacturing, or testing.
• Strong understanding of relevant standards: EN 60601, EN 62304, EN 62366, etc.
• Excellent written English skills (reports are reviewed/queried in English).
• Knowledge of Technical File codes (per COMMISSION IMPLEMENTING REGULATION (EU) 2017/2185) desirable: MDA0201, MDA0202, MDA0203, MDA0204, MDA0301, MDA0302, MDA0303, MDA0304, MDA0305, MDA0306, MDA0307, MDA0308, MDA0309, MDA0310, MDA0311, MDA0312, MDA0313, MDA0314, MDA0315, MDA0316, MDA0317, and MDA0318.

Benefits & Perks 🎉

• Work for a globally recognized and stable company, a leader in the TIC industry.
• Enjoy a flexible schedule and remote work model.
• Access SGS University and Campus for continuous learning.
• Thrive in a multinational environment, collaborating globally.
• Comprehensive benefits package.

Why SGS? 🤗

At SGS, we foster an open, friendly, and supportive team environment. We value diversity and offer opportunities for learning, growth, and fulfilling your potential.

Apply Now! ➡️