Regulatory Affairs Specialist

Fresenius Medical Care

  • Huthwaite, Nottinghamshire
  • Permanent
  • Full-time
  • 6 hours ago
Regulatory Affairs AssociateAre you a detail-oriented professional with a strong background in regulatory affairs, and pharmacovigilance? Are you looking to make a real impact in a dynamic, fast-paced pharmaceutical environment?We’re seeking a Regulatory Affairs Associate to support our Regulatory Compliance Manager (RCM) in ensuring that our operations stay at the forefront of regulatory excellence and patient safety while also helping us drive forward best practices in compliance, product information, and pharmacovigilance.This is a full-time role of 37.5 hours, working Monday to Friday, 9am - 5pm. This is a hybrid role, our head office based in Huthwaite, Nottinghamshire.What does the role involve?You will:
  • Lead local pharmacovigilance (PV) activities, ensuring systems, reporting, and processes meet MHRA and GVP standards
  • Support regulatory submissions (e.g. licence applications, product updates) and keep product information up to date
  • Review promotional and non-promotional materials to ensure they comply with ABPI/IPHA codes
  • Work closely with Marketing and internal teams to provide clear, compliant advice and guidance
  • Deliver training on ABPI codes and PV requirements, and monitor compliance performance
About You, you will:
  • A degree in a life science discipline (e.g., Pharmacy, Pharmacology, Chemistry, Biology, Nursing)
  • Experience reviewing promotional materials under the ABPI Code
  • Knowledge of GVP, MDR, Human Medicines Regulation, and medical device vigilance
  • Excellent written and verbal communication skills
  • A proactive, adaptable mindset with the ability to prioritise in a fast-changing environment
  • Ideally have experience in regulatory submissions and medical device complaint handling (training can be provided)
What can we offer you?Here at Fresenius Medical Care, we value the contribution of our people and ensure that we offer industry-leading rewards and progression.We offer a competitive salary alongside a wealth of other fantastic benefits listed below:
  • 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
  • bhsf RISE - our Health and Wellbeing hub 24/7 access to GP's and Counsellors
  • Blue Light card – providing thousands of amazing discounts online and on the high street
Who is Fresenius Medical Care?We are the leading provider of dialysis services to the NHS, operating 52 partnership dialysis units that together provide regular dialysis treatment to over 3,800 NHS patients in the UK. We are part of a global company treating over 344,000 patients worldwide across over 4,000 clinics.We also operate 44 production sites on all continents to provide dialysis products such as dialysis machines, dialysers and related disposables. 1 in every 2 of all dialysis machines used around the globe are manufactured by Fresenius Medical Care and we are the 3rd largest medical devices company in the world.Regulatory Affairs Assistant posts will be subject to a Basic DBS DisclosureFresenius Medical Care is an equal opportunities employer

Fresenius Medical Care