Senior Manager Medical Devices PMS & PMCF

Help protect patients and keep our medical device portfolio safe, compliant, and evidence-backed throughout its full lifecycle. In this role, you will lead post-market clinical evidence activities that strengthen confidence with regulators, healthcare professionals, and internal teams, while ensuring ongoing readiness for audits under the EU Medical Device Regulation.

As Senior Manager for Post-Market Surveillance and Post-Market Clinical Follow-up, you will own the strategy and execution of post-market clinical evidence for a portfolio of medical devices used in adult medical nutrition. Your work will directly support ongoing patient safety, performance monitoring, and benefit-risk confidence in real-world use, as well as the quality of our technical documentation and inspection readiness.

About the job

You will translate real-world data into clear, defensible conclusions, and ensure insights are consistently reflected in core regulatory and quality deliverables. You will also help strengthen ways of working across functions so that post-market evidence becomes a reliable, repeatable system rather than a one-off effort.

You will

• Own the post-market evidence strategy for your device portfolio, ensuring post-market surveillance and clinical follow-up plans are robust, proportionate, and aligned to EU MDR expectations.
• Design and lead real-world clinical evidence activities such as surveys, observational studies, clinical data collection, and literature monitoring, with a focus on scientific quality, data integrity, and regulatory acceptability.
• Turn post-market data into decisions and documentation, confirming continued safety and performance, and feeding outcomes into clinical evaluation, risk management, and periodic safety reporting.
• Be audit-ready by design, acting as a confident point of contact during inspections and audits, and clearly defending strategy, rationale, execution, and conclusions.
• Drive cross-functional alignment and continuous improvement, partnering with Regulatory Affairs, Quality, Medical Affairs, Clinical Operations, and R&D, and improving templates, processes, and vendor collaboration where needed.

About you

You Have

• A scientific degree (MSc or PhD) in life sciences, biomedical sciences, medicine, clinical research, or a closely related discipline.
• Practical experience in medical devices within post-market surveillance, post-market clinical follow-up, clinical research, clinical operations, regulatory affairs, or a related evidence-focused area.
• Strong working knowledge of the EU Medical Device Regulation, particularly requirements for post-market surveillance and post-market clinical follow-up.
• Hands-on experience writing and maintaining high-quality plans and reports, including post-market surveillance plans and post-market clinical follow-up plans and evaluation reports.
• Confidence working with real-world data approaches such as observational research, surveys, registries, and structured literature reviews, including the ability to interpret results and draw clear benefit-risk conclusions.
• Clear, concise written English and strong stakeholder skills, you can align diverse teams and communicate complex topics in a practical way.
• A structured, accountable working style, comfortable owning priorities and maintaining inspection-level documentation quality.

Nice-to-haves

• Experience in medical nutrition, enteral feeding, or critical care devices, or exposure to healthcare professional user environments.
• Experience supporting interactions with external audit bodies or regulatory inspections, including preparing evidence packs and defending rationale.
• Experience working with external partners, vendors, or consultancies to execute post-market evidence activities.
• Familiarity with post-market requirements outside the EU, or experience working across multiple regulatory environments.
• Confidence engaging clinical experts and key opinion leaders to design evidence collection that is feasible and meaningful.

You will work in a cross-functional, matrix environment that connects clinical science, quality systems, regulatory strategy, and product lifecycle management. Day to day, you will partner closely with colleagues in Regulatory Affairs, Quality, Medical Affairs, Clinical Operations, and R&D to ensure post-market insights translate into strong documentation and practical actions.

This role suits someone who enjoys building alignment, bringing clarity to complex evidence questions, and improving systems. You will have room to shape how post-market evidence is planned, executed, and reused across the organisation, while collaborating with external clinical experts and service providers when needed.

About Danone

At Danone, you will be part of a company working to create real benefits for people, communities, and the planet through brands like Nutricia and Nutrilon. You will be part of one of the largest Certified B Corps™ in the world.

Our state-of-the-art research and innovation centre builds bridges between food and science and is global in reach, founded on experience in life and food science, technology, and user experience, and is at the forefront of pioneering advances in specialized nutrition.

We offer

All Danoners receive a complete package of benefits. This includes a competitive salary and yearly bonus, a premium free pension, 30 days of annual leave (with the opportunity to purchase more), and a monthly health care allowance. In addition, you can get discount on your gym membership, and we offer initiatives focused on nutrition, physical, and mental health. We provide continuous learning opportunities through workshops, online courses, and training sessions.