Global Product Monitoring Vigilance Report Writer
On-siteParis, Île-de-France, France
Job Summary
Lead French vigilance reporting activities and ensure compliance with applicable regulations by reviewing adverse events, complaints, and field issues to determine reportability requirements. Serve as a key point of contact for interactions involving French Competent Authorities, preparing and submitting vigilance reports within required regulatory timelines. Support post-market surveillance planning, reporting, and compliance activities for products marketed in France, including reviewing trends to identify emerging issues and supporting field safety corrective actions. Collaborate with Quality, Regulatory Affairs, and Product teams to maintain vigilance documentation and records while supporting inspections, audits, and regulatory enquiries.
Required Qualifications
- Significant experience in medical device vigilance, post-market surveillance, product safety or pharmacovigilance
- Strong working knowledge of French medical device vigilance requirements
- Experience preparing and managing submissions to French regulatory authorities
- Understanding of EU MDR vigilance requirements and complaint handling processes
- Strong technical writing and documentation skills
- Proven ability to evaluate adverse events and determine reportability
- Experience working within regulated medical device or healthcare environments
Desired Qualifications
- Direct interaction with French Competent Authorities
- Field Safety Corrective Actions (FSCA) and vigilance investigations
- Medical device complaint handling and adverse event assessment
- Post-market surveillance reporting under EU MDR
- Quality Management Systems and audit support activities
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