Manager, EMEA Safety and Compliance en Insulet

Are you a strategic leader with a passion for patient safety and regulatory excellence? Do you thrive in complex, fast-paced environments and enjoy building high-performing teams? We’re looking for a Manager of EMEA Safety & Compliance to lead post-market surveillance and regulatory interactions across the UK, Benelux, DACH, and the Netherlands.

This is a pivotal role in our global Quality & Regulatory Affairs team, where you’ll drive safety and compliance initiatives, lead a small team, and collaborate cross-functionally to ensure our medical technologies meet the highest standards.

Key Responsibilities

• Lead Regional Safety & Compliance: Oversee post-market surveillance (PMS) and vigilance activities across EMEA, ensuring alignment with global standards and local regulatory requirements.
• Team Leadership: Manage and mentor a small, high-performing team, fostering a culture of autonomy, collaboration, and trust.
• Regulatory Engagement: Serve as the primary liaison with Competent Authorities, responding to safety inquiries and adverse event analyses.
• Cross-Functional Collaboration: Partner with Legal, Medical Affairs, QA/RA, and commercial teams to support field actions, CAPAs, and safety communications.
• Audit & Inspection Readiness: Support internal and external audits, including those by notified bodies and regulatory authorities.
• Complaint & Risk Management: Lead the Critical Complaint Triage (CCT) process and contribute to health hazard evaluations and risk file reviews.
• Market Expansion Support: Guide safety and compliance strategy for new product launches and market entries in the region.

What You’ll Bring

• Proven experience managing teams in a regulated medical device, life sciences, or healthcare environment.
• Strong understanding of EMEA medical device regulations, including EUMDR, FDA, ISO 13485, and ISO 14971.
• Demonstrated ability to work autonomously, manage ambiguity, and drive initiatives with minimal oversight.
• Experience working directly with Competent Authorities and supporting regulatory audits.
• Excellent communication and technical writing skills, with the ability to translate complex scientific data into clear, actionable insights.
• Proficiency in Microsoft Office and comfort with learning new technologies quickly.

Preferred Qualifications

• Clinical background (e.g., BSN, Registered Dietician, Diabetic Educator) or experience in SaMD.
• Experience leading global or cross-regional teams.
• Familiarity with post-market safety principles and compliance documentation (e.g., PMS plans, CAPAs, HHEs).

Why Join Us?

You’ll be part of a mission-driven organization committed to improving patient outcomes through innovation and integrity. This role offers the opportunity to shape regional safety strategy, influence global practices, and grow your leadership impact in a dynamic, international setting.

Ready to make a difference?
Apply now and help us ensure the safety and reliability of life-changing medical technologies across EMEA.

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!

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