Product Assessor - MDR (Cardiovascular Devices)
SGS North America Inc.

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 98,000 employees operate a network of 2,650 offices and laboratories, working together to enable a better, safer and more interconnected world.

Our Innovation Factory promotes and develops digital innovation initiatives across SGS; we deliver solutions to the business at scale and speed. Our mission is to create a better, safer and connected world by supporting, improving or augmenting our physical operations with digital technologies.

Job Description

As a Product Assessor, you will play a pivotal role in conducting cardiovascular and soft tissue product assessments and technical file reviews in strict adherence to the European Medical Device Directive (MDD) and Medical Device Regulation (MDR) for Class IIa/IIb and/or Class III devices.

Key Responsibilities:

• Conduct thorough assessments of cardiovascular and neurovascular implants under relevant commission regulation codes, as well as other surgically invasive cardiovascular/neurovascular devices.
• Identify and rectify instances where device technical files deviate from compliance with applicable requirements.
• Provide support for CE marking activities within SGS, contribute to the training and qualification of junior staff, and develop comprehensive training materials.
• Communicate effectively with team members, clients, and other stakeholders regarding product assessments, working diligently to minimize regulatory risks associated with medical device certification.

Qualifications

We are seeking an experienced candidate with:

• Four years of professional experience within the healthcare products domain or related activities, encompassing roles in design, manufacturing, auditing, or research. Among these, a minimum of two years should involve direct engagement in the design, manufacture, testing, or utilization of the specific device or technology slated for assessment or be closely tied to the scientific aspects under evaluation.
• Extensive experience in the field of medical devices, particularly in cardiovascular and/or neurovascular devices, gained through roles in R&D, manufacturing, or other engineering disciplines.
• Devices such as stents, guidewires, catheters, shunts, coils, or other endovascular devices used in central circulatory, coronary, or neurological procedures would be of particular interest.
• Medical device knowledge on MDA/MDN/MDS codes for MDR listed in Commission implementing regulation (EU) 2017/2185
• Prior experience in conducting Cardiovascular and Soft Tissue Product Assessments for another Certification/Notified body (Technical File reviewer) is advantageous.
• Degree or equivalent qualification in a related discipline such as medicine, engineering, or biomedical science.
• Proficient communication skills using modern electronic platforms.
• Strong written English skills, as reports will be reviewed and queried in English.
• Demonstrated skills in independent learning.
• Desirable: Medical device technical knowledge of one or more non-active devices, as per commission regulation 2017/2185.

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