At a Glance
- Tasks: Lead regulatory compliance and quality assurance for medical devices in the UK and Ireland.
- Company: Join Medtronic, a leader in healthcare innovation and access.
- Benefits: Competitive salary, flexible benefits, and a commitment to employee well-being.
- Other info: Opportunity for growth and collaboration with regulatory agencies.
- Why this job: Make a real impact on healthcare while developing your career in a dynamic environment.
- Qualifications: Experience in Regulatory Affairs and strong leadership skills 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.
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).
Regulatory Affairs Manager UK&I in Watford employer: Dormont Manufacturing Co
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. Our commitment to employee growth is evident through comprehensive training programmes and leadership development opportunities, ensuring that you can thrive in your career while contributing to our mission of improving patient outcomes. Located in the UK, you'll enjoy a competitive salary and flexible benefits package, all within a supportive environment that values your contributions and promotes work-life balance.
StudySmarter Expert Advice🤫
We think this is how you could land Regulatory Affairs Manager UK&I in Watford
✨Join Compliance Communities
Get involved in compliance and risk communities — both online and offline. Look for forums, LinkedIn groups, or even local meetups where compliance pros hang out. You never know who might drop a job opportunity your way!
✨Attend Industry Conferences
Keep an eye out for compliance and risk management conferences and workshops in your area. These events are a goldmine for networking, and they often have job boards or recruiters on-site looking for new talent. Plus, it’s a chance to learn what's trending in the field.
✨Leverage Your University Career Services
If you’ve recently graduated or are still studying, head over to your university's career services. Many companies, including those in compliance, actively recruit fresh talent through these services, so make sure you tap into that resource.
✨Showcase Your Knowledge Online
Start writing articles or blog posts about compliance topics that interest you. Share them on platforms like LinkedIn to demonstrate your knowledge and passion. This not only builds your presence in the field but can also catch the attention of companies like Dormont Manufacturing Co looking for candidates who are engaged and informed.
We think you need these skills to ace Regulatory Affairs Manager UK&I in Watford
Some tips for your application 🫡
Show Your Understanding of Compliance:In the compliance-risk field, it's super important to showcase your understanding of regulations and risk management frameworks. Highlight any relevant coursework, certifications (like ICA or AML), or even projects that demonstrate your knowledge and commitment to this area. We want to see how you can navigate this complex landscape!
Quantify Your Achievements:When detailing your experience, try to quantify your achievements. For example, if you've previously worked on a project that improved compliance metrics or reduced risk exposure, give us the numbers! This data-driven approach really stands out to hiring managers in compliance-risk roles.
Tailor Your CV to Reflect Relevant Skills:Make sure your CV highlights skills that are particularly relevant to compliance, like attention to detail, analytical thinking, and report writing. Ensure these are easy to spot – consider using bullet points to break down your responsibilities and achievements for maximum impact!
Craft a Motivating Cover Letter:In your cover letter, let us know why you’re excited about the compliance-risk role at Dormont Manufacturing Co. Share what motivates you about compliance, and how you believe you can contribute to our mission. This is your chance to showcase not only your skills but also your passion for this important field!
How to prepare for a job interview at Dormont Manufacturing Co
✨Master the Regulations
Brush up on key compliance regulations relevant to the industry you're applying to. Familiarising yourself with specific laws and frameworks used in your field will give you an edge during technical questions. Show that you’re not just aware of them but can also apply them—think real-life scenarios!
✨Show Your Analytical Skills
Compliance roles really focus on analytical skills, so be prepared for case studies or situational questions during the interview. We've got to demonstrate how we approach risk assessments or compliance audits, possibly drawing on examples from past experiences or university projects. Bring some thoughtful case scenarios to discuss!
✨Know Your Tools
Get comfortable with commonly used compliance software and tools. Familiarity with platforms like RSA or MetricStream can really impress during your interview, as it shows you're ready to hit the ground running. If you’ve had any experience with them, make sure to highlight that!
✨Align with Company Culture
Since it's a full-time position, show your long-term commitment and interest in the company’s mission and values. Dive into how your ethics and professional philosophy align with Dormont Manufacturing Co’s stance on compliance. A shared vision can really resonate with interviewers looking for fit as much as skill!
