France Vigilance Expert: Medical Device Regulatory Writer

Insulet Corporation; Paris; On-site; EUR 70,000 - 90,000; Full time

Job summary

Insulet Corporation seeks an experienced Medical Device Vigilance Specialist with deep expertise in French vigilance requirements and direct experience working with French Competent Authorities. The role focuses on ensuring compliance with post-market surveillance and vigilance obligations in France, serving as the country-specific expert.

You will lead vigilance reporting activities, review adverse events, manage submissions to French authorities, and collaborate with Quality, Regulatory

Qualifications

• Significant experience in medical device vigilance/post-market surveillance.
• Strong working knowledge of French vigilance requirements.
• Experience preparing and managing submissions to French regulatory authorities.
• Understanding of EU MDR vigilance requirements and complaint handling processes.

Responsibilities

• Lead French vigilance reporting activities and ensure compliance with applicable regulations.
• Serve as a key point of contact for interactions involving French Competent Authorities.
• Review adverse events, complaints and field issues to determine reportability requirements.
• Prepare, submit and manage vigilance reports within required regulatory timelines.
• Support post-market surveillance planning, reporting and compliance activities for products marketed in France.
• Review trends, complaint data and safety information to identify emerging issues.
• Support field safety corrective actions where required.
• Collaborate with Quality, Regulatory Affairs and Product teams to ensure regulatory compliance.
• Maintain vigilance documentation and records in accordance with quality system requirements.
• Support inspections, audits and regulatory enquiries related to French vigilance obligations.

Skills

French vigilance requirements

Post-market surveillance

Regulatory authority liaison

EU MDR vigilance understanding

Technical writing

Adverse event evaluation

Education

Experience in pharmacovigilance or regulatory affairs (medical devices)

Job description

Insulet Corporation seeks an experienced Medical Device Vigilance Specialist with deep expertise in French vigilance requirements and direct experience working with French Competent Authorities. The role focuses on ensuring compliance with post-market surveillance and vigilance obligations in France, serving as the country-specific expert.

You will lead vigilance reporting activities, review adverse events, manage submissions to French authorities, and collaborate with Quality, Regulatory