Product Specialist for Active Medical Devices
hace 2 semanas
Company Overview
Sgs Socièté Générale De Surveillance SA is a global leader in testing, inspection, and certification.
About the Role
We are seeking an experienced Product Specialist to join our team of professionals dedicated to providing high-quality services for active medical devices. This role offers a unique opportunity to leverage your expertise and contribute to the growth and success of our organization.
Job Description
The successful candidate will be responsible for conducting technical documentation reviews and ensuring compliance with EU regulations and standards. They will also support and guide a team of product assessors, collaborate with cross-functional teams to increase efficiency and quality, and develop training programs to enhance the skills of their colleagues.
Required Skills and Qualifications
To be eligible for this position, you should have:
- A minimum of four years of professional experience in the field of healthcare products or related activities;
- A strong background as a Product Assessor/Specialist/Technical File Reviewer within a notified body for active devices;
- Active Medical Devices knowledge through designing, manufacturing, or testing of such devices;
- Thorough knowledge and understanding of related standards: EN 60601, EN 62304, EN 62366, etc.;
- Good written English skills as reports will be reviewed queried in English;
- Knowledge of the following Technical File codes desirable as per COMMISSION IMPLEMENTING REGULATION (EU) 2017/2185 of 23 November 2017: MDA0201, MDA0202, MDA0203, MDA0204, MDA0301, MDA0302, MDA0303, MDA0304, MDA0305, MDA0306, MDA0307, MDA0308, MDA0309, MDA0310, MDA0311, MDA0312, MDA0313, MDA0314, MDA0315, MDA0316, MDA0317, and MDA0318.
Benefits
This position offers a competitive salary range of $80,000 - $120,000 per annum, depending on experience, plus a comprehensive benefits package that includes flexible work arrangements, access to ongoing training and development opportunities, and the chance to work with a dynamic team of professionals who share your passion for delivering high-quality services.
Why Sgs?
Sgs Société Générale De Surveillance SA is a globally recognized and stable company that offers a supportive culture, endless opportunities to learn and grow, and a rewarding work environment that thrives on teamwork and collaboration.
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