Product Assessor / Senior Product Assessor - Active Devices

About the Role

The day-to-day responsibilities of this role will include managing a small team of globally based Product Assessors, conducting technical documentation reviews, and providing guidance and support to ensure the highest level of service is provided throughout the SGS network. You will also be responsible for developing training and presenting it to others, as well as assisting with technical queries and sales-related inquiries.

The Medical Device team at SGS is a dynamic and experienced group of professionals who are passionate about enabling a better, safer, and more interconnected world. As a Senior Product Assessor, you will be working closely with this team to ensure that the highest level of service is provided to clients and stakeholders.

What You Will Do

• Conduct thorough technical documentation reviews to ensure compliance with EU regulations and standards
• Manage a small team of globally based Product Assessors, providing guidance and support to ensure the highest level of service
• Collaborate with cross-functional teams to increase efficiency and quality
• Develop training and present it to others in SGS or externally as deemed necessary
• Assist with technical queries and those related to sales within the Active Medical Devices field
• Ensure that the highest level of service is provided throughout the SGS network
• Support and guide your team of talented Product Assessors
• Monitor the team's technical competence, KPIs, and wellbeing, providing feedback and support when there are concerns
• Conduct recruitment, including reviewing CVs and undertaking interviews, and support with onboarding of new starters

What We Are Looking For

• Prior experience as a Product Assessor/Specialist/Technical File Reviewer within another Notified Body for active devices, conducting reviews against MDD and/or MDR
• Four years of professional experience in the field of healthcare products or related activities, such as design, manufacturing, auditing, or research
• Active Medical Devices knowledge (monitoring equipment, therapeutic devices, devices utilizing radiation, stand-alone software devices, etc.) through designing, manufacturing, or testing of such devices
• Thorough knowledge and understanding of related standards: EN 60601, EN 62304, EN 62366, etc.
• Good written English skills (as reports will be reviewed/queried in English)
• Knowledge of the following Technical File codes desirable (as per COMMISSION IMPLEMENTING REGULATION (EU) 2017/2185 of 23 November 2017): MDA0201, MDA0202, MDA0203, MDA0204, MDA0301, MDA0302, MDA0303, MDA0304, MDA0305, MDA0306, MDA0307, MDA0308, MDA0309, MDA0310, MDA0311, MDA0312, MDA0313, MDA0314, MDA0315, MDA0316, MDA0317, and MDA0318

Nice to Have

• Experience with conducting technical documentation reviews for a variety of medical devices
• Knowledge of EU regulations and standards, including MDD and MDR
• Experience with recruitment and onboarding of new starters
• Strong leadership and management skills, with the ability to guide and support a team of Product Assessors

Benefits and Perks

• Opportunity to work with a globally recognized company and make a significant impact in the field of certification
• Collaborative and dynamic work environment with a team of experienced professionals
• Professional development opportunities, including training and certification programs
• Competitive salary and benefits package
• Flexible working hours and remote work options
• Access to a global network of professionals and opportunities for career advancement
• Comprehensive health and wellness programs, including mental health support and employee assistance programs
• Paid time off and holidays, including a generous vacation package
• Retirement savings plan and employee stock purchase plan

• Tip: Before applying, review the job description and requirements carefully to ensure you have the necessary skills and experience.
• Tip: Be prepared to provide specific examples of your experience conducting technical documentation reviews and ensuring compliance with EU regulations and standards.
• Tip: Research the company and the Medical Device team to understand their goals and values, and be prepared to explain how you can contribute to their success.
• Tip: Practice your leadership and management skills, as you will be responsible for guiding and supporting a team of Product Assessors.
• Tip: Be prepared to discuss your knowledge of Active Medical Devices and related standards, as well as your experience with recruitment and onboarding of new starters.
• Tip: Consider creating a portfolio of your work, including examples of technical documentation reviews and training programs you have developed, to demonstrate your skills and experience to potential employers.
• Tip: Don't be afraid to ask questions during the interview process, such as what the typical career path is for a Product Assessor at SGS, or what opportunities there are for professional development and advancement.