Regulatory Affairs & Quality Specialist

Regulatory Affairs & Quality Specialist

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 110,000 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.

• 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.

Join our passionate team and help shape healthcare worldwide!

We are seeking a Regulatory Affairs & Quality Specialist to lead and manage regulatory activities across the full product lifecycle within the assigned country. This role ensures all regulatory requirements for medicines are planned, executed, and maintained in full compliance with international, regional, and local regulations.

You will support the successful approval, launch, and ongoing availability of products, overseeing activities from development and registration through to post‑market surveillance. The role plays a key part in driving consistency, efficiency, and alignment of regulatory practices at a country level.

As a subject matter expert, you will provide ongoing regulatory guidance, ensuring continuous compliance and supporting business objectives within a highly regulated environment.

** This is a full‑time Hybrid role of 37.5 hours, working Monday to Friday, 9am - 5pm. Our head office is based in Huthwaite, Nottinghamshire.**

• Act as the main contact for regulatory authorities and internal teams.
• Manage regulatory activities across the full product lifecycle, from approval to post‑market compliance.
• Support product registrations, submissions, and timely market launches.
• Provide regulatory advice to ensure compliance with local and global requirements.
• Work closely with cross‑functional teams and external partners.
• Take responsibility for local pharmacovigilance activities, including safety reporting and audit support.
• Act as the key contact for PV matters with global teams and health authorities.
• Maintain and update marketing authorisations, ensuring all documentation is accurate and compliant.
• Review product labelling, artwork, and promotional materials.
• Monitor regulatory changes and share key updates with stakeholders.
• Ensure compliance with internal procedures and regulatory standards.
• Support training, process improvements, and compliance tracking activities.

• Degree in Pharmacy, Life Sciences, or a related discipline.
• Proven experience in Regulatory Affairs within the pharmaceutical or Med Tech industry.
• Hands‑on experience with regulatory submissions, compliance, and product lifecycle management.
• Understanding of pharmacovigilance and GDP requirements.
• Strong knowledge of relevant regulations, standards (e.g. GxP, ISO), and local compliance requirements.
• Highly organised, with the ability to manage multiple tasks and deadlines.
• Analytical and detail‑oriented, with good problem‑solving skills.
• Effective…