Job Description
As a Product Assessor, you will be responsible for conducting comprehensive assessments of Cardiovascular and 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:
1. Support CE marking activities carried out by SGS.
2. Contribute to the training and qualification of junior staff, including the creation of training materials.
3. 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 Cardiovascular and Soft Tissue devices is required.
Preferred Experience:
4. Experience conducting Cardiovascular and Soft Tissue Product Assessments for another Certification/Notified body (Technical File reviewer) is advantageous.
Education:
5. Degree or equivalent qualification in a relevant discipline such as medicine, pharmacy, engineering, or other related sciences.
Skills:
6. Strong communication skills, especially through electronic mediums.
7. Proficiency in written and verbal English, as reports will be reviewed and queried in English.
8. 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 (, IUDs, urethral stents, bariatric devices, biliary stents).MDN 1201 – Non-active non-implantable devices for anaesthesia, emergency, and intensive care (, pleural drainage devices, endotracheal tubes, introducers).MDN 1202 – Non-active non-implantable devices for administration, channelling, and removal of substances (, dialysis devices, intravenous lines, hypodermic needles, catheters).MDN 1204 – Non-active non-implantable devices for wound and skin care (, wound dressings, sutures, surgical gloves).MDN 1206 – Non-active non-implantable ophthalmologic devices (, contact lenses, eye drops).MDN 1210 – Non-active non-implantable devices for contraception or prevention of sexually transmitted diseases (, condoms, contraceptive diaphragms).MDN 1213 – Non-active non-implantable devices composed of substances to be introduced into the body via a body orifice (, gels, moisturisers).MDN 1214 – General non-active non-implantable devices used in healthcare (, ultrasound gels).