23-11-22 13:16:00 2030 Anvers

Product Assessor Active Devices/ Software


  • SGS Belgium nv
  • 2030 Anvers
  • Pharma & Soins de santé
  • Durée indéterminée
  • Contrat permanent
  • A plein temps
Postuler

SGS est une société internationale d’inspection, de vérification, de testing et de certification. La société emploie plus de 97.000 personnes et dispose d’un réseau de plus de 2600 bureaux et laboratoires dans le monde.

Plus d'informations

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.

Intéressé(e)?

Contactez votre consultant

Lorane Molineaux

+32 478 50 77 03

Postuler en ligne

Contactez-nous

Soumettez-nous votre défi RH. Ensemble, nous examinerons comment nous pouvons vous aider.

Dernières offres d'emplois