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Regulatory Affairs Quality Administrator Benelux

- Zaventem

Job content

1. Ensure compliance with products distributed by the company

  • Ensure follow-up complaints Processing processes related to product quality with Benelux production units including materio vigilance, recalls and FSCA activities etc.
  • Ensure training of medical representatives on Medical Vigilance
  • Ensure providing of requested documents such as declarations of conformity, CE certificates and user manuals
  • Ensure preparation of KPI’s
  • Ensure participation in tenders and providing RAQ related information
  • Ensure follow-up on corrective actions in response to the event of a CAPA,  non-conformance and/or observations during the quality audit
  • Ensure the submitting of RECUPEL, Val-i-Pac etc.
  • Prepare and follow-up purchase orders within the Ariba / Esker system
  • Ensure booking of travel and accommodation
  • Organize trainings and prepare training materials

2. Ensure regulatory and normative surveillance in connection with Belgian medical device regulation

  • Ensure regulatory and normative surveillance in connection with Belgian medical device regulation
  • Provide relevant internal local about the regulations in the Benelux regarding medical devices / pharmaceutical products

3. Quality Management system within the company

  • Support Maintenance of the Quality Management system and (re) certify certification according to ISO (ISO 9001- ISO 13485) certification
  • Participate in group audits (RA / QA / HSE)
  • Bachelor or master degree
  • Minimum 2 years of work experience in a similar position in the field of medical devices or in pharmaceutical company
  • Knowledge of the regulations regarding medical devices,
  • Knowledge on Material Vigilance
  • Microsoft Office, knowledge of traceability and complaints treatment systems desirable eg.SAP, Pilgrim
  • Punctuality / Strictness
  • Good priority management & organisational skills
  • Analytical & synthetic spirit
  • Good communication skills at and with all levels
  • Team spirit
  • Dutch & English, French is an advantage

Aline Vandermeeren 0497715810