Cluster Lead for Medical Device Regulatory Affairs and Vigilance

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.

Within the 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.

Systems, Quality & Regulatory (SQR), a global function within Care Enablement, ensures Fresenius Medical Care's products meet the highest standards of quality, safety, and regulatory compliance throughout the entire product lifecycle.

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 licences 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:

We offer a competitive salary alongside a wealth of benefits including:

• 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 discounts online and at high street retailers