Medical Device Assessor
hace 2 días
Company Overview
We are SGS, a global benchmark for sustainability, quality, and integrity. With 99,600 employees operating in over 2,600 offices and laboratories, we enable a better, safer, and more interconnected world.
Job Summary
As a Medical Device Assessor at SGS, you will be responsible for conducting comprehensive assessments of Cardiovascular and Soft Tissue products to ensure technical file reviews comply with the European Medical Device Regulation (MDR), Medical Device Directive (MDD), and UKCA regulations for Class IIa/IIb and/or Class III devices.
About the Role
You will support CE marking activities, contribute to junior staff training and qualification, and communicate effectively with team members and clients regarding product assessments. Your goal is to minimize risks associated with medical device certification and maintenance.
Requirements
The ideal candidate has extensive experience in healthcare products or related activities, such as design, manufacturing, regulation, auditing, or research. Specific experience in Cardiovascular and Soft Tissue devices is required. Preferred experience includes conducting product assessments for another Certification/Notified body.
Qualifications
Degree or equivalent qualification in a relevant discipline like medicine, pharmacy, engineering, or other sciences. Strong communication skills, proficiency in written and verbal English, and in-depth knowledge of medical devices within specific non-active categories are essential.
Estimated Salary Range
$80,000 - $110,000 per annum, depending on location and experience.
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