Global Product Monitoring Vigilance Report Writer

Job Summary

Are you an experienced Medical Device Vigilance or Pharmacovigilance professional looking to broaden your international exposure?

We are seeking a Post Market Surveillance & Vigilance Specialist to support global patient safety activities across multiple markets.

This role offers the opportunity to work with cross-functional teams worldwide, contributing to complaint handling, adverse event reporting, post-market surveillance activities, trend analysis, regulatory compliance, and continuous improvement initiatives.

This is an excellent opportunity for someone who enjoys combining technical vigilance expertise with global stakeholder engagement in a growing, highly regulated environment.

What You'll Do

• Manage and support complaint handling and post-market surveillance activities across international markets.
• Review and investigate adverse events and product complaints.
• Assess reportability and prepare vigilance submissions in accordance with applicable regulatory requirements.
• Support Medical Device Reporting (MDR) and other global vigilance obligations.
• Analyse complaint, reliability and product performance data to identify trends and potential safety signals.
• Conduct device history record reviews and support investigations into product issues.
• Partner with Quality, Regulatory Affairs, Customer Care, Manufacturing and Engineering teams globally.
• Contribute to audit readiness and support inspections conducted by regulatory authorities and notified bodies.
• Develop reports, dashboards and documentation to support compliance and decision-making.
• Provide training and guidance to colleagues on complaint and vigilance processes.
• What You'll Bring
• Experience within medical device vigilance, post-market surveillance, complaint handling, product safety or pharmacovigilance.
• Strong understanding of MDR vigilance requirements and adverse event reporting processes.
• Experience assessing reportability and preparing regulatory submissions.
• Ability to interpret and analyse safety, complaint or reliability data.
• Strong written communication skills, including technical and regulatory writing.
• Experience working within regulated healthcare, medical device, pharmaceutical or life sciences environments.
• Ability to collaborate effectively with international stakeholders.
• Particularly Attractive Experience EU MDR, UK MDR or global vigilance reporting.
• International market exposure.
• Complaint investigation and trend analysis.
• Medical device quality systems (ISO 13485) or equivalent.
• FDA reporting or global post-market surveillance programmes.

Why Join Us?

Work with stakeholders across Europe, North America and other global markets.

Contribute directly to patient safety and product quality.

Expand your international regulatory and vigilance expertise.

Be part of a collaborative, mission-driven environment committed to improving lives.

About Insulet Corporation

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!

Please read our Privacy Notice to learn how Insulet handles your personal information when you apply for a vacancy with us here.

Insulet Corporation is proud to be an equal opportunity employer.

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran. (Know Your Rights)

Insulet employees are all focused on the same goal - to make a difference.

Our relentless passion is to simplify life for people with diabetes.

We excite and empower employees to bring their best selves to work through a culture that supports a healthy work and life balance.

We set the bar high to meet customer needs, and our priority is to ensure our employees are equipped and supported to help us get there.

We foster and celebrate curiosity, innovation, and learning.

Our teams work collaboratively and are empowered to drive the best actions for our customers.

Our innovation spirit and customer-minded focus position us as global pioneers - leading the way to improve health outcomes with revolutionary medical devices while breaking down barriers to access.

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