At a Glance
- Tasks: Lead regulatory compliance and quality assurance for medical devices in the UK and Ireland.
- Company: Join Medtronic, a leader in global healthcare technology and innovation.
- Benefits: Competitive salary, flexible benefits, and a commitment to employee well-being.
- Other info: Dynamic work environment with opportunities for personal and professional growth.
- Why this job: Make a real impact on healthcare access and equity while leading a passionate team.
- Qualifications: Experience in Regulatory Affairs and Quality within the medical device industry required.
The predicted salary is between 71760 - 107640 £ per year.
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: 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.
Regulatory Affairs Manager UK&I in Watford employer: Medtronic
At Medtronic, we pride ourselves on fostering a culture of innovation and collaboration, where every employee is empowered to make a meaningful impact in healthcare. As a Regulatory Affairs Manager for the UK and Ireland, you will not only lead a dedicated team but also benefit from a competitive salary and flexible benefits package that supports your career growth and personal well-being. Join us in our mission to alleviate pain and restore health, while enjoying the unique opportunity to work at the forefront of medical technology in a supportive and dynamic environment.
StudySmarter Expert Advice🤫
We think this is how you could land Regulatory Affairs Manager UK&I in Watford
✨Tip Number 1
Network like a pro! Reach out to folks in the regulatory affairs space, especially those at Medtronic. A friendly chat can open doors and give you insights that a job description just can't.
✨Tip Number 2
Prepare for interviews by diving deep into Medtronic's mission and values. Show us how your experience aligns with our commitment to healthcare access and innovation. We love candidates who are passionate about making a difference!
✨Tip Number 3
Don’t just wait for job postings! Keep an eye on our website and apply directly. We often have roles that might not be advertised widely, and applying through our site gives you a better chance to stand out.
✨Tip Number 4
Brush up on your regulatory knowledge! Stay updated on UK and EU regulations, especially those related to medical devices. Being well-informed will not only impress us but also show your commitment to the field.
We think you need these skills to ace Regulatory Affairs Manager UK&I in Watford
Some tips for your application 🫡
Tailor Your CV:Make sure your CV is tailored to the Regulatory Affairs Manager role. Highlight your experience in regulatory compliance and quality systems, especially within the medical device industry. We want to see how your skills align with what we’re looking for!
Craft a Compelling Cover Letter:Your cover letter is your chance to shine! Use it to explain why you’re passionate about regulatory affairs and how you can contribute to our mission at Medtronic. Don’t forget to mention any leadership experience you have, as that’s key for this role.
Showcase Your Communication Skills:Strong communication is crucial in this role, so make sure to demonstrate your interpersonal skills in your application. Whether it’s through your writing style or examples of past experiences, let us see how you can influence and engage with others.
Apply Through Our Website:We encourage you to apply directly through our website. It’s the best way to ensure your application gets into the right hands. Plus, you’ll find all the details you need about the role and our company culture there!
How to prepare for a job interview at Medtronic
✨Know Your Regulations
Familiarise yourself with the key regulations and standards relevant to the role, such as ISO 13485 and the requirements of the MHRA and HPRA. Being able to discuss these confidently will show your expertise and commitment to regulatory compliance.
✨Showcase Leadership Skills
Prepare examples that highlight your leadership experience, especially in developing teams and managing projects. Medtronic values strong leaders, so be ready to discuss how you've successfully led teams in the past and how you can bring that to their UKI QRA team.
✨Stay Updated on Industry Changes
Research recent changes in regulatory affairs within the medical device industry. Being able to discuss current trends and how they might impact Medtronic will demonstrate your proactive approach and strategic thinking abilities.
✨Prepare for Scenario Questions
Think about potential scenarios you might face in the role, such as handling audits or post-market surveillance issues. Prepare structured responses that showcase your analytical skills and problem-solving abilities, as these are crucial for success in this position.
