Regulatory Affairs Specialist

We are seeking an experienced Regulatory Affairs Specialist to support post-market regulatory activities for medical devices. The role includes field safety corrective actions, regulatory authority inquiries, complaint process support, and regulatory documentation requests from customers, sales teams, and internal stakeholders. Responsibilities may include the following and other duties may be assigned:

• Monitor and interpret regulatory requirements for the UK and Ireland, ensuring updates are implemented in compliance with regulatory standards
• Coordinate and support Field Safety Corrective Actions (FSCAs), working with sales teams and the FCA Support Team to ensure timely completion
• Manage and respond to inquiries from Competent Authorities, including maintaining accurate regulatory records and reporting
• Provide guidance to sales teams on product complaint handling and returns to ensure compliance with regulations and internal procedures
• Support product registration and "placing on the market" activities, providing country-specific regulatory guidance
• Manage regulatory documentation requests from customers, tender teams, and internal stakeholders, ensuring accurate and timely responses
• Coordinate requests with relevant internal teams and ensure appropriate follow-up and resolution
  
  Experience in medical device regulatory
• Strong computer skills, including Microsoft Office (especially Excel) and the ability to work with internal systems
• Strong analytical, problem-solving, and organizational skills
• Ability to work independently and manage multiple tasks effectively
• Detail-oriented with a strong focus on quality and patient safety
  
  At Medtronic you can begin a life-long career of exploration and innovation, while helping champion healthcare access and equity for all. You'll lead with purpose, breaking down barriers to innovation in a more connected, compassionate world.
  
  Medtronic offers a competitive Salary and flexible Benefits Package
A commitment to our employees lives at the core of our values. We recognize their contributions. They share in the success they help to create. We offer a wide range of benefits, resources, and competitive compensation plans designed to support you at every career and life stage. Pay range / Rango salarial / Intervalo salarial /Fascia retributiva / Tranche de salaire / Gehaltsband / Salaribereik: United Kingdom: 40,000.00 GBP - 60,000.00 GBP | This position is eligible for a short-term incentive called the Medtronic Incentive Plan (MIP). About Medtronic We lead global healthcare technology and boldly attack the most challenging health problems facing humanity by searching out and finding solutions. Our Mission - to alleviate pain, restore health, and extend life - unites a global team of 95,000+ passionate people. We are engineers at heart- putting ambitious ideas to work to generate real solutions for real people. From the R&D lab, to the factory floor, to the conference room, every one of us experiments, creates, builds, improves and solves. We have the talent, diverse perspectives, and guts to engineer the extraordinary. Learn more about our business, mission, and our commitment to diversity