Cluster Lead, Medical Device Pre & Post Market Surveillance

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.

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.

Qualifications

• Degree in a natural science field.
• 5–8 years regulatory affairs experience in pharma, biotech or medical devices.
• 5–8 years working across multiple countries.
• 3+ years of leadership experience in healthcare or 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 and GxP.
• Strong understanding of global and regional regulatory frameworks.
• High proficiency in English and the local language.
• Skilled in MS Office and regulatory/document management systems.
• Willingness to travel within EMEA when needed.

Company

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, we work with purpose, compassion and a global team of over 125,000 employees.

Benefits

• 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