Regulatory Affairs Manager UK&I

At Medtronic you can begin a life-long career of exploration and innovation while helping champion healthcare access and equity for all. Youll lead with purpose breaking down barriers to innovation in a more connected compassionate world.

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.

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.

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 95000 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