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Regulatory Affairs Manager UK&I

Medtronic -
Watford

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Job details

Full-time
£71,760 - £107,640 a year

Qualifications

Analysis skills
Project management
Organisational skills
Leadership
Communication skills

Full job description

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.

A Day in the Life

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

Physical Job Requirements

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.

Benefits & Compensation

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: 71,760.00 GBP - 107,640.00 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 here

Apply Now

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regulatory affairs jobs in flitwick, bdf

Regulatory Affairs Manager UK&I

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Title Medical Director UK/Ireland

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