Product Assessor - Soft Tissue Team

Product Assessor

You will also:

• Support CE marking activities carried out by SGS.
• Contribute to the training and qualification of junior staff, including the creation of training materials.
• Communicate effectively with team members and clients regarding product assessments, working to minimize risks associated with medical device certification and maintenance.

Qualifications:

Specific experience in the design, manufacture, testing, or use of Soft Tissue devices is required.

Preferred Experience:

• Experience conducting Soft Tissue Product Assessments for another Certification/Notified body (Technical File reviewer) is advantageous.

Education

• Degree or equivalent qualification in a relevant discipline such as medicine, pharmacy, engineering, or other related sciences.

Skills

• Strong communication skills, especially through electronic mediums.
• Proficiency in written and verbal English, as reports will be reviewed and queried in English.
• In-depth knowledge of medical devices within the following non-active categories (as per Commission Regulation 2017/2185):
• MDN 1104 Non-active soft-tissue and other implants (e.g., IUDs, urethral stents, bariatric devices, biliary stents). Specifically long term invasive implants such as IUDs, ophthalmic devices, and surgical sutures.
• MDN 1202 Non-active non-implantable devices for administration, channelling, and removal of substances (e.g., dialysis devices, intravenous lines, hypodermic needles, catheters). Specifically non-invasive channelling and storing devices such as blood bags or similar.
• MDN 1206 Non-active non-implantable ophthalmologic devices (e.g., contact lenses, eye drops, other instruments for ophthalmological surgery).
• MDN 1214 General non-active non-implantable devices used in healthcare (e.g., ultrasound gels).