Regulatory Affairs & Quality Specialist
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.
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. 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 (37.5 hours) hybrid role, Monday to Friday, 9 a.m. – 5 p.m. Head office 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, 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.
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.
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 (with 12 months service)
- Long Service Vouchers
- Cycle to Work Scheme
- Employee Assistance Program (EAP)
- Blue Light card – providing thousands of 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.
#J-18808-Ljbffr…