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.
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.
Systems, Quality & Regulatory (SQR) is a global function within Care Enablement that ensures 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.
We are seeking a Regulatory Affairs & Quality Specialist to lead and manage regulatory activities across the full product lifecycle within the assigned country and ensure all regulatory requirements for medicines are planned, executed, and maintained in full compliance with international, regional, and local regulations.
Key responsibilities include overseeing product registrations, submissions, and market launches, providing regulatory advice, maintaining marketing authorisations, reviewing labelling and promotional materials, monitoring regulatory changes, and supporting pharmacovigilance activities.
The role plays a key part in driving consistency, efficiency, and alignment of regulatory practices at a country level.
Full‑time Hybrid role of 37.5 hours, Monday to Friday, 9am to 5pm, based in Huthwaite, Nottinghamshire.
Your Responsibilities
- Act as the main contact for regulatory authorities and internal teams.
- Manage regulatory activities across the full product lifecycle.
- 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.
Your Profile
- Degree in Pharmacy, Life Sciences, or a related discipline.
- Proven experience in Regulatory Affairs within the pharmaceutical or MedTech 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 communicator with strong stakeholder management and collaboration skills.
- Confident working across cross‑functional teams and with external partners (e.g., regulators, suppliers).
- Proactive mindset with a focus on continuous improvement and compliance excellence.
- Comfortable using IT systems and standard business tools (e.g., MS Office, collaboration platforms).
- Fluent in English; additional languages are an advantage.
- Willingness to travel as required.
Our Offer For You
We provide a competitive salary plus a range of benefits designed to support your personal and professional development.
Benefits
- Company Pension Scheme
- Life Assurance
- 33 days holiday (inclusive of 8 days bank holiday), increasing with service
- Company‑paid health cash plan
- Annual leave purchase scheme (after 12 months service)
- Long‑service vouchers
- Cycle to Work Scheme
- Employee Assistance Program (EAP)
- Blue Light card – providing discounts online and on the high street
Regulatory Affairs & Quality Specialist posts will be subject to a Basic DBS Disclosure.
Fresenius Medical Care is an equal opportunities employer.
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