AdresseThis position is reporting to the Quality & Regulatory Compliance manager France, the role include the following missions:
Post-Market Surveillance:
- Materiovigilance for the Vascular division : Products Complaint handling: registration, reporting to manufacturing and to relevant competent authorities
- Liaise with customers, physicians, sales team to document and investigate the complaints
- coordinate follow up questions to investigate the product complaints
- Provide feedback to customers, eg. evaluation letters, technical reports, as required.
- Monitor returns, liaising with field staff and customer service
- Back up within the France and Benelux quality organization
Field safety and corrective actions support:
- manage local field action and products recall
Quality System Abbott Vascular (AV):
- Quality system management: Ensure local procedures are up-to-date; relevant to current/best practices and that they meet the Quality System requirements.
- Ensure that the AV Quality System requirements are communicated, understood, and applied at the affiliates level.
- Quality e-learning management – training plan assignement and review. training records
- Corrective Action – Preventive Action (CAPA) management
- Prepare, execute and follow-up on internal/external audits.
- Internal and external Suppliers Quality Management
- Quality KPI – reporting in the quality management reviews
Other:
- Support Tender team for regulatory and environment purposes
- Customers support for regulatory questions, products specification etc.
- Medical Devices Regulatory environment intelligence
- Participation to the French trade association (SNITEM) meetings
Knowledge and Skills
- Bachelor's or Master's Degree (scientific and/or quality and/or Medical Devices regulation), or equivalent experience required in the medical device/pharmaceutical environment (pharmacy or biology or biotechnology or biomedical)
- First experience in the quality or regulatory field is preferred but not mandatory
- Native or Fluent French language
- Strong written and verbal English communication skills,
