At a Glance
- Tasks: Lead regulatory compliance and quality assurance for medical devices in the UK and Ireland.
- Company: Join Medtronic, a global leader in healthcare technology.
- Benefits: Competitive salary, flexible benefits, and a commitment to employee well-being.
- Other info: Dynamic work environment with opportunities for career growth and development.
- Why this job: Make a real impact on health solutions while leading a passionate team.
- Qualifications: Experience in Regulatory Affairs and strong leadership skills required.
The predicted salary is between 71760 - 107640 £ per year.
The Quality & Regulatory Affairs Manager for the UK and Ireland is responsible for regulatory compliance, post-market surveillance, and quality system compliance to ISO 13485 for Medtronic Ltd. This role leads the UKI QRA team and serves as the primary contact with UK and Irish regulatory agencies, including the Medicines and Healthcare products Regulatory Agency (MHRA), the Health Products Regulatory Authority (HPRA), and relevant Health Technology Assessment (HTA) bodies. The Manager provides regulatory expertise for local projects and ensures compliance with UK and EU requirements.
Responsibilities may include the following, and other duties may be assigned:
- Lead and develop the UKI Quality & Regulatory Affairs team
- Own and maintain UKRP, Human Tissue Import Licence, and BioPharma Import Licence activities for Medtronic Ltd, acting as the main contact for relevant authorities
- Monitor regulatory changes across the UK and EU, assess impact, and drive updates to regional and local procedures
- Coordinate internal and external audits and inspections
- Maintain ISO 13485 certification
- Oversee Post-Market Surveillance activities in the UK and Ireland, including field safety corrective actions, notifications, execution reporting, and responses to MHRA and HPRA requests for additional information
- Deploy enterprise QRA strategy and initiatives across UKI
- Provide and/or coordinate local training on regulatory affairs and quality topics
Required Knowledge and Experience:
- Significant experience in Regulatory Affairs and Quality within the medical device industry
- Proven leadership and people development experience
- Strong communication, interpersonal, and influencing skills
- Hands-on, rigorous approach with strong analytical and strategic thinking abilities
- Solid organizational and project management skills
The above statements are intended to describe the general nature and level of work being performed by employees assigned to this position, but they are not an exhaustive list of all the required responsibilities and skills of this position.
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: United Kingdom: 71,760.00 GBP- 107,640.00 GBP. This position is eligible for a short-term incentive called the Medtronic Incentive Plan (MIP).
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.
Regulatory Affairs Manager UK&I in Watford employer: Covidien
Medtronic Ltd is an exceptional employer, offering a dynamic work environment where innovation meets purpose. As a leader in global healthcare technology, we provide our employees with competitive salaries, flexible benefits, and ample opportunities for professional growth within the medical device industry. Our commitment to diversity and employee recognition fosters a collaborative culture that empowers individuals to make a meaningful impact on health outcomes across the UK and Ireland.
