Product Assessor - Soft Tissue Team

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:

• 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 Cardiovascular and Soft Tissue devices is required.

Preferred Experience:

• Experience conducting Cardiovascular and 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.
• Indepth knowledge of medical devices within the following nonactive categories (as per Commission Regulation 2017/2185):
  • MDN 1104 Nonactive softtissue and other implants (e.g. IUDs urethral stents bariatric devices biliary stents).
  • MDN 1201 Nonactive nonimplantable devices for anaesthesia emergency and intensive care (e.g. pleural drainage devices endotracheal tubes introducers).
  • MDN 1202 Nonactive nonimplantable devices for administration channelling and removal of substances (e.g. dialysis devices intravenous lines hypodermic needles catheters).
  • MDN 1204 Nonactive nonimplantable devices for wound and skin care (e.g. wound dressings sutures surgical gloves).
  • MDN 1206 Nonactive nonimplantable ophthalmologic devices (e.g. contact lenses eye drops).
  • MDN 1210 Nonactive nonimplantable devices for contraception or prevention of sexually transmitted diseases (e.g. condoms contraceptive diaphragms).
  • MDN 1213 Nonactive nonimplantable devices composed of substances to be introduced into the body via a body orifice (e.g. gels moisturisers).
  • MDN 1214 General nonactive nonimplantable devices used in healthcare (e.g. ultrasound gels).

Additional Information :

• Join a globally recognized and stable company a leader in the Testing Inspection and Certification (TIC) industry.
• Enjoy a flexible schedule and remote work model.
• Access continuous learning opportunities through SGS University and Campus.
• Collaborate in a multinational environment with colleagues from various continents.
• Benefit from a comprehensive benefits platform.

Apply Now:
At SGS we are committed to fostering an open friendly and supportive culture that thrives on teamwork. We value diversity and provide endless opportunities to learn grow your expertise and fulfill your potential. Apply now to join our motivated and dynamic team!

Remote Work :

Yes

Employment Type :

Fulltime