Cluster Lead for Medical Device Regulatory Affairs and Vigilance

At Fresenius Medical Care, we are the global leader in kidney care, committed to improving the lives of patients with chronic kidney disease. Our mission is to deliver high-quality, innovative products, services, and care across the entire healthcare journey. Guided by our vision—“Creating a future worth living. For patients. Worldwide. Every day.”—we work with purpose and compassion, supported by a global team of over 125,000 employees.

Within our Care Enablement segment, we develop and provide life-sustaining medical products, digital health solutions, and therapies that empower clinical teams and improve patient outcomes. Our FME Reignite strategy drives transformation through innovation, efficiency, and sustainable growth.

Our values guide how we work:

• We Care for our patients, each other, and our communities
• We Connect across teams and borders to deliver excellence together
• We Commit to doing things the right way— growing with purpose and leading kidney care with integrity and innovation

Systems, Quality & Regulatory (SQR), a global function within Care Enablement ensuring Fresenius Medical Care’s products meet the highest standards of quality, safety, and regulatory compliance throughout the entire product lifecycle. The team supports market access, innovation, and patient safety by driving excellence across manufacturing and supply chain, overseeing post‑market surveillance, and promoting continuous improvement and system harmonization. SQR also manages regulatory and quality data governance and provides critical product‑related business services across global operations.

The Cluster Lead oversees all medical device regulatory activities across an assigned EMEA cluster, ensuring timely, compliant market authorisations and ongoing product availability. The role provides regulatory expertise across the full product lifecycle covering submissions, assessments, registrations, renewals, vigilance, and post‑market surveillance. They ensure continuous compliance, manage regulatory risks, and support business continuity and patient safety. The position also leads a team of Country/Cluster Experts to deliver consistent, high‑quality regulatory and post‑market activities.

Your Responsibilities:

• Lead and develop a regulatory team across the EMEA cluster, ensuring clear goals, strong performance, and effective resource planning.
• Manage regulatory submissions, registrations, renewals, and variations for medical devices across assigned countries.
• Maintain compliant regulatory documentation and licenses and support regulatory strategy development.
• Act as the main regulatory contact for authorities, notified bodies, distributors, and internal teams.
• Support audits and inspections and respond to regulatory inquiries with accurate, timely information.
• Provide clear regulatory updates, risk assessments, and recommendations to management and cross‑functional partners.
• Ensure full compliance with applicable regulations and internal SOPs.
• Monitor regulatory changes, assess impacts, and share relevant intelligence with stakeholders.
• Serve as Local Safety Officer, overseeing vigilance, incident reporting, and post‑market surveillance activities.
• Manage authority notifications, safety documentation, and risk‑related activities throughout the product lifecycle.
• Collaborate with Quality and global safety teams to maintain device safety and compliance standards.
• Provide regulatory training and support the development of junior team members.

Your Profile:

• Degree in a natural science field.
• 5–8 years regulatory affairs experience in pharma/biotech/medical devices.
• 5–8 years working across multiple countries.
• 3+ years of leadership experience in healthcare/MedTech.
• Experience working with regulatory authorities in the UK and an understanding of regional requirements across the EMEA region.
• Strong knowledge of UK MDR, FDA regulations, EU MDR, and post‑market surveillance/ vigilance requirements.
• Strong leadership, communication, and stakeholder management skills.
• Able to manage multiple projects, deadlines, and regulatory challenges.
• Knowledge of ISO 9001, ISO 13485, GxP.
• Strong understanding of global/regional regulatory frameworks.
• High proficiency in English and local language.
• Skilled in MS Office and regulatory/document management systems.
• Willingness to travel within EMEA when needed.

Our Offer For You:

There is a lot you can discover at Fresenius Medical Care, regardless in which field you are an expert and how much experience you have - all dedicated to your professional journey. Whether in front of or behind the scenes - you are helping to make ever better medicine available to more and more people around the world.

Individual opportunities for self‑determined career planning and professional development.

A corporate culture in which there is enough room for innovative thinking - to find the best solution together, not the quickest one.

A large number of committed people with a wide range of skills, talents and experience.

The benefits of a successful global corporation with the collegial culture of a medium‑size company.

We offer a competitive salary alongside a wealth of other fantastic benefits listed below:

• Company Pension Scheme
• Life Assurance
• 33 Days Holiday (inclusive of 8 days bank holiday) increasing with service
• Annual leave purchase scheme (with 12 months service)
• Company paid health cash plan
• Long Service Vouchers
• Cycle to Work Scheme
• Employee Assistance Program (EAP)
• Blue Light card – providing thousands of amazing discounts online and on the high street