At Medtronic you can begin a life-long career of exploration and innovation, while helping champion healthcare access and equity for all. Youu2019ll 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.u202f
**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 u2014 to alleviate pain, restore health, and extend life u2014 unites a global team of 95,000+ passionate people.
We are engineers at heartu2014 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 (http://www.medtronic.com)
We lead global healthcare technology and boldly attack the most challenging health problems facing humanity by searching out and finding solutions.
Our Mission u2014 to alleviate pain, restore health, and extend life u2014 unites a global team of 95,000+ passionate people.
We are engineers at heartu2014 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.
**We change lives** . Each team member, each day, helps to improve and redefine how the world treats the most pressing health conditions, from heart disease to diabetes. Our industry leadership comes from the passion and ingenuity of our people. Thatu2019s who we are. Working alongside one another, we use science, medicine, and a profound understanding of the human body to build extraordinary technologies that can transform lives.
**We build extraordinary solutions as one team** . With one Medtronic Mindset defining how we work. Speed and decisiveness run through our DNA. Diverse perspectives inspire our bold answers to any challenge that comes our way. And we deliver results the right way, breakthrough after patient breakthrough.
**This life-changing career is yours to engineer** . By bringing your ambitious ideas, unique perspective and contributions, you willu2026
**Build** a better future, amplifying your impact on the causes that matter to you and the world **Grow** a career reflective of your passion and abilities **Connect** to a dynamic and inclusive culture that welcomes the challenge of life-long learning
These commitments set our team apart from the rest:
**Experiences that put people first** . Respect for people is the hallmark of our humanity. It fuels our team to positively impact even a single life. And it means we put our people first at Medtronic as well, creating a culture of belonging and always pushing to get you the career-building resources you need.
**Life-transforming technologies** . No matter your role, you contribute to technologies that transform lives. What we build empowers patients to live life on their terms.
**Better outcomes for our world** . Here, itu2019s about more than the bottom line. Our Mission to improve human welfare drives us. We advance healthcare, society, and equity with every design, inside and outside our walls.
**Insight-driven care** . Fresh viewpoints. Cutting-edge AI, data, and automation. You’re shaping the future of healthcare technology and defining the next generation of breakthroughs in care
It is the policy of Medtronic to provide equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by federal, state or local law. In addition, Medtronic will provide reasonable accommodations for qualified individuals with disabilities.
For sales reps and other patient facing field employees, going into a healthcare settingu202fis considered an essential function of the job and we expect our employees to comply with all credentialing requirements at the hospitals or clinics they support.
This employer participates in the federal E-Verify program to confirm the identity and employment authorization of all newly hired employees. For further information about the E-Verify program, please click here (https://www.e-verify.gov/employees) .
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