Senior Product Assessor, Active Devices

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 teams 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 code is mandatory (as per COMMISSION IMPLEMENTING REGULATION (EU) 2017/2185 of 23 November 2017) : MDA 0314
• 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 0305 MDA 0306 MDA 0312 MDA 0317

Please submit your CV in English.

Additional Information :

Why SGS

• Global and very stable company world leader in the TIC (Testing Inspection and Certification) industry.
• Flexible schedule and hybrid model.
• SGS university and Campus for continuos learning options.
• Multinational environment where you will work with colleagues from multiple continents.
• Benefits platform.

Join Us: At SGS we believe in innovation collaboration and continuous improvement.  We offer a supportive and inclusive work environment that encourages professional growth and personal development. 

Remote Work :

Yes

Employment Type :

Full-time