French Medical Device Vigilance Lead & Reporting Specialist

Insulet Corporation; Paris; Hybrid; EUR 70,000 - 100,000; Full time

Job summary

Insulet Corporation is seeking an experienced Medical Device Vigilance Specialist to ensure French post-market surveillance and vigilance obligations are met. This role focuses on navigating the French regulatory environment and serving as the subject matter expert on French vigilance.

You will lead reporting activities, interact with French authorities, and support inspections and quality system requirements across the organization.

Qualifications

• Extensive experience in medical device vigilance or pharmacovigilance.
• Strong understanding of French vigilance requirements and EU MDR.
• Experience preparing submissions to French regulatory authorities.

Responsibilities

• Lead French vigilance reporting and ensure regulatory compliance.
• Be the main contact for interactions with French Competent Authorities.
• Review adverse events and field issues to determine reportability.

Skills

Vigilance

Post-market surveillance

Regulatory liaison

Adverse event review

Job description

Insulet Corporation is seeking an experienced Medical Device Vigilance Specialist to ensure French post-market surveillance and vigilance obligations are met. This role focuses on navigating the French regulatory environment and serving as the subject matter expert on French vigilance.

You will lead reporting activities, interact with French authorities, and support inspections and quality system requirements across the organization.