23/11/2022 13:16:00 2030 Antwerpen

Product Assessor Active Devices/ Software

  • SGS Belgium nv
  • 2030 Antwerpen
  • Pharmaceutical and Healthcare
  • Onbepaalde duur
  • Vast contract
  • Voltijds
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SGS is wereldleider op het gebied van inspectie, controle, analyse en certificering en staat bekend als de global benchmark voor kwaliteit en integriteit.

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  • 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.


  • 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.


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Lorane Molineaux

+32 478 50 77 03

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