11/23/2022 1:16:00 PM 2030 Antwerp

Product Assessor Active Devices/ Software


  • SGS Belgium nv
  • 2030 Antwerp
  • Pharmaceutical and Healthcare
  • Indefinite period
  • Permanent contract
  • Fulltime
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SGS is the world’s leading inspection, verification, testing and certification company, recognized as the global benchmark for quality and integrity. With more than 89,000 employees, SGS operates a network of more than 2,600 offices and laboratories around the world.

More info

Position

  • Conduct technical file reviews of Class IIa/IIb and/or Class III devices against European Medical Device Directive and Medical Device Regulation
  • Ensure that reviews are technically sound and in compliance with all applicable requirements;
  • Conduct product assessments (primarily desk-based, but occasionally on-site) in accordance with established procedures, maintaining a high standard of service delivery;
  • Assist with queries raised from product assessments;
  • Support the training and qualification of more junior staff and create training materials;
  • Maintain personal competence and development in qualified specialist areas to be able to assess product technical documentation on an ongoing basis;
  • Ensure adherence to SGS policies, procedures and processes; work at all times to adhere to KPIs set as an individual and within a team; ensure full compliance with the Company’s Code of Integrity & Professional Conduct.

Profile

  • University or technical college degree
  • Lead Auditor Qualification (desirable).
  • +4 years of professional experience in the field of healthcare products or related activities, such as in the design, manufacturing, auditing or research
  • Active Medical Devices knowledge (monitoring equipment, therapeutic devices, devices utilising radiation, stand-alone software devices, etc), through designing, manufacturing or testing of such devices;
  • Knowledge of Artificial Intelligence is a strong asset;
  • Thorough knowledge and understanding of related standards: EN 60601, EN 62304, EN 62366, etc;
  • 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.

We would like to hear from candidates based in Europe and Asia. Relocation will not be necessary for this position.

Interested?

Contact your consultant

Lorane Molineaux

+32 478 50 77 03

Apply online

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