PRODUCT ASSESSOR - ACTIVE DEVICE / SOFTWARE AS A MEDICAL DEVICE
SGS North America Inc.

Job Info

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Company Description

We are delighted that you're thinking about a career with SGS!

We currently have an exciting opportunity at SGS for a Product Assessor - Active Devices to join our highly successful certification division.

We offer a competitive salary with fantastic benefits including a annual bonus (discretionary and subject to eligibility criteria UK), Enhanced maternity/paternity and adoption pay, Birthday Leave and much more!.

SGS are the global leader and innovator in inspection, verification, testing and certification services. Trusted all over the world, SGS is a market leader because we put 100% passion, pride and innovation into everything we do. We encourage new ideas. We welcome people who challenge the way we do things. And we will be 100% committed to helping you reach your full potential.

At SGS, we have an open corporate and international culture, we offer a dynamic work environment in a leading global company. Our high professional standards and our sustainability approach guarantee you a future-oriented work environment. We invest in our employees for the long term and we are committed to supporting your development within the company.

Our business principles include: Integrity, Health, Safety & Environment, Quality & Professionalism. Respect, Sustainability and Leadership

Job Description

Working as a member of our Medical Device team, you will conduct technical file reviews against European Medical Device Directive and Medical Device Regulation for Class IIa /IIb and/or Class III. You will ensure that reviews are technically sound and in compliance with all applicable requirements. Additionally, you will support the training and qualification of more junior staff, and create training materials.

More specifically, you will:

• Ensure regulatory compliance of product technical file assessment under applicable EU Medical Devices Directives and / or Regulations;
• Conduct product assessments (primarily desk-based, but occasionally may be on-site) in accordance with established procedures, maintaining a high standard of service delivery;
• Maintain personal competence and development in qualified specialist areas to be able to assess product technical documentation on an ongoing basis;
• Project manage assessments as appropriate, to maximise efficiencies, enhance client satisfaction, and ensure compliance with requirements;
• Assist with queries raised from product assessments;
• Work at all times to adhere to KPIs set as an individual and within a team;
• Ensure that the highest level of service is provided throughout the SGS network offering medical devices certification and stakeholders through efficient service delivery.

Qualifications

• Four 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, testing or use of the device or technology to be assessed or related to the scientific aspects to be assessed;
• Active Medical Devices knowledge (Monitoring equipment, therapeutic devices, devices utilising radiation, stand-alone software devices, etc), 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: MDA0201, MDA0202, MDA0203, MDA0204, MDA0301, MDA0302, MDA0303, MDA0304, MDA0305, MDA0306, MDA0307, MDA0308, MDA0309, MDA0310, MDA0311, MDA0312, MDA0313, MDA0314, MDA0315, MDA0316, MDA0317, MDA0318.

This job has expired.