Product Assessor / Senior Product Assessor - Orthopaedics

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Company Description

We are SGS - the world's leading testing, inspection and certification company. We are recognized as the global benchmark for sustainability, quality and integrity. Our 99,500 employees operate a network of 2,500 offices and laboratories, working together to enable a better, safer and more interconnected world.

Job Description

As a Product Assessor, you'll be responsible for conducting Orthopaedics related technical file reviews in compliance with all applicable requirements including the UK and EU Medical device regulation for Class IIa/IIb and Class III. You'll ensure that products are safe and perform as intended and in compliance with all applicable requirements.

You'll also support CE marking activities carried out by SGS, support in training and qualification of more junior staff, and create training materials.

You'll communicate with team members and clients regarding the product assessment or other activities performed and work to minimize risks associated with medical device certification.

Qualifications

For application, please submit English CV.

The successful candidate will bring a minimum of 4 years professional experience in the field of healthcare products or related activities, such as in design, manufacturing, auditing, or research, of which two years shall be in the design, manufacture, and testing related to MDN1102 and joint replacement.

Experience of conducting Orthopaedic assessments for another Certification/Notified body (Technical File reviewer) would be advantageous.

In addition, the ideal candidate will also bring:

• Degree or equivalent level qualification linked to relevant studies e.g., medicine, engineering, or other relevant sciences.
• Good communication techniques through electronic mediums.
• Good written English skills (as reports will be reviewed/queried in English).
• Medical device knowledge in any of the following:
• Non-active osteo- and orthopaedic implants (MDN1102):
• Prosthetic joint replacements (i.e., knee, hip, shoulder, elbow, wrist, ankle, fingers, etc. implants).
• Artificial spinal disc, spinal cages...
• Bone graft substitute for orthopaedic indications, bone cements, etc.
• Osteosynthesis devices such as orthopaedic nails, screws, plates, etc.

Additional Information

• We provide a hybrid working environment.
• Opportunity to work with a global leader in inspection, verification, testing, and certification.
• Collaborative and inclusive work environment.
• Competitive salary and benefits package.
• Opportunities for professional growth and development.

Join Us: At SGS, we are dedicated 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.