Senior Product Assessor, Active Devices

Job Description

Are you ready to take your career to the next level? If you have a strong background as a Product Assessor within an EU notified body conducting MDD/MDR technical documentation review, then we have an exhilarating opportunity for you!

Join our dynamic team at SGS and become a Senior Product Assessor - Active Devices. This role will allow you to make a significant impact in the field of certification.

As a member of our Medical Device team, you will not only manage a small team of globally based Product Assessors but also dive deep into the exciting world of Active Medical Devices.

It is remote based, and we are open to candidates located everywhere across Europe and India. But they must hold a valid work permit for their country of residency.

Your Responsibilities Will Include:

• Supporting and guiding your team of talented Product Assessors
• Conducting thorough technical documentation reviews and ensuring compliance with EU regulations and standards.
• Collaborating with cross-functional teams to increase efficiency and quality
• Monitoring the team's technical competence, KPIs, and wellbeing and providing feedback and support when there are concerns.
• Conduct recruitment, including reviewing CVs and undertaking interviews and supporting with onboarding of new starters
• Develop training and present the training 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 offering medical devices certification and stakeholders through efficient service delivery.

Qualifications

To be eligible for this role, you should have prior experience as a Product Assessor/Specialist/Technical File Reviewer within another Notified Body for active devices, conducting reviews against MDD and/or MDR.

Additionally, You Must Possess:

• Four years of professional experience in the field of healthcare products or related activities, such as design, manufacturing, auditing, or research, of which two years shall be in the design, manufacture, testing, or use of the device or technology to be assessed or related to the scientific aspects to be assessed;
• 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 is mandatory (as per COMMISSION IMPLEMENTING REGULATION (EU) 2017/2185 of 23 November 2017) : MDA 0304 & MDA 0314 (MUST HAVE).
• Knowledge of the following Technical File code is would be a great addition (as per COMMISSION IMPLEMENTING REGULATION (EU) 2017/2185 of 23 November 2017) : MDA 0203, MDA 0301, MDA 0302, MDA 0303, MDA 0305, MDA 0306, MDA 0308, MDA 0312, MDA 0317

Please submit your CV in English.