At a Glance
- Tasks: Lead regulatory compliance and quality assurance for innovative medical devices.
- Company: Join Medtronic, a leader in global healthcare technology.
- Benefits: Competitive salary, flexible work arrangements, and comprehensive benefits package.
- Other info: Opportunity to work with passionate professionals dedicated to transforming lives.
- 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.
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
- 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.
Benefits & CompensationMedtronic 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: Medtronic plc
At Medtronic, we pride ourselves on being an exceptional employer, offering a dynamic and inclusive work culture that prioritises employee growth and well-being. Located in Watford, Hertfordshire, our team enjoys flexible work arrangements, competitive compensation, and a comprehensive benefits package, all while contributing to life-changing healthcare solutions that make a real difference in people's lives.
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 people in the industry, especially those already at Medtronic. A friendly chat can open doors and give you insider info on what they're really looking for.
✨Tip Number 2
Prepare for the interview by knowing your stuff! Brush up on regulatory affairs trends and Medtronic's latest innovations. Show them you're not just a candidate, but a passionate expert ready to contribute.
✨Tip Number 3
Practice makes perfect! Do mock interviews with friends or use online resources. The more comfortable you are talking about your experience and skills, the better you'll shine during the real deal.
✨Tip Number 4
Don't forget to apply through our website! It’s the best way to ensure your application gets seen. Plus, it shows you're genuinely interested in joining the Medtronic team.
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 relevant experience in regulatory compliance and quality management, especially within the medical device industry. We want to see how your skills align with our mission!
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 team. Be sure to mention any specific experiences that relate to the responsibilities listed in the job description.
Showcase Your Leadership Skills:Since this role involves leading a team, don’t forget to highlight your leadership experience. Share examples of how you've developed teams or managed projects successfully. We love seeing candidates who can inspire and guide others!
Apply Through Our Website:We encourage you to apply directly through our website for the best chance of success. It’s the easiest way for us to track your application and ensure it gets the attention it deserves. Plus, you’ll find all the details you need right there!
How to prepare for a job interview at Medtronic plc
✨Know Your Regulations
Familiarise yourself with the key regulations and standards relevant to the medical device industry, especially ISO 13485. Being able to discuss these in detail will show your expertise and readiness for the role.
✨Showcase Leadership Skills
Prepare examples of how you've led teams or projects in the past. Highlight your ability to develop others and drive compliance initiatives, as this role requires strong leadership in regulatory affairs.
✨Stay Updated on Changes
Research recent changes in UK and EU regulations that could impact Medtronic. Demonstrating your proactive approach to staying informed will impress interviewers and show your commitment to the field.
✨Prepare for Scenario Questions
Anticipate scenario-based questions related to post-market surveillance and audits. Think through how you would handle specific situations, as this will demonstrate your analytical and strategic thinking abilities.
