Product Assessor

Job Description As a Product Assessor , you will be responsible for conducting comprehensive assessments of Soft Tissue products, ensuring technical file reviews adhere to all applicable requirements, including the European Medical Device Regulation (MDR), Medical Device Directive (MDD), and UKCA for Class IIa/IIb and/or Class III devices. Your role will involve ensuring that these assessments are technically sound and compliant with relevant regulations. 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: The ideal candidate will have extensive experience in healthcare products or related activities, such as design, manufacturing, regulation, auditing, or research. 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).