Global Product Monitoring Vigilance Report 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

Job Summary

We are seeking an experienced Medical Device Vigilance Specialist with deep expertise in French vigilance requirements and direct experience working with French Competent Authorities. This position is focused on ensuring compliance with French post-market surveillance and vigilance obligations. Unlike broader international roles, this opportunity is ideal for someone who has built significant expertise navigating the French regulatory environment and wants to be recognised as a subject matter expert.

What You'll Do

• 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.

What You'll Bring

• 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.

Particularly Attractive Experience

• 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.

Why Join Us?

• Become the recognised French vigilance expert within the organisation.
• Influence patient safety and regulatory compliance activities.
• Work in a role that values specialist country expertise.
• Contribute to improving outcomes for patients using innovative medical technologies.

Insulet Corporation (NASDAQ: PODD), headquartered in Massachusetts, is an innovative medical device company dedicated to simplifying life for people with diabetes and other conditions through its Omnipod product platform. The Omnipod Insulin Management System provides a unique alternative to traditional insulin delivery methods. With its simple, wearable design, the tubeless disposable Pod provides up to three days of non-stop insulin delivery, without the need to see or handle a needle. Insulet’s flagship innovation, the Omnipod 5 Automated Insulin Delivery System, integrates with a continuous glucose monitor to manage blood sugar with no multiple daily injections, zero fingersticks, and can be controlled by a compatible personal smartphone in the U.S. or by the Omnipod 5 Controller. Insulet also leverages the unique design of its Pod by tailoring its Omnipod technology platform for the delivery of non-insulin subcutaneous drugs across other therapeutic areas. For more information, please visit insulet.com and omnipod.com.

We are looking for highly motivated, performance-driven individuals to be a part of our expanding team. We do this by hiring amazing people guided by shared values who exceed customer expectations. Our continued success depends on it!