Careers that Change Lives

　　The Digital Technologies team is based in London, England. The ideal candidate for this role will be based in the UK, Europe, or eastern US with remote eligibility. Ability to travel to relevant sites (up to 25%).

　　A career at Medtronic is like no other. We’re purposeful. We’re committed. And we’re driven by our Mission to alleviate pain, restore health and extend life for millions of people worldwide. We look for accountable leaders who have a clear vision of where we are going and how to get there, bold inclusive thinkers who create new ideas and bring our best solutions forward to benefit our patients, business partners, and customers.

　　We believe that when people from different cultures, genders, and points of view come together, innovation is the result —and everyone wins. Medtronic walks the walk, creating an inclusive culture where you can thrive.

　　Bring your talents to an industry leader in medical technology and healthcare solutions – we’re a market leader and growing every day. You can be proud to be a part of technologies that are rooted in our long history of mission-driven innovation. You will be empowered to shape your own career. We encourage and support your growth with the training, mentorship, and guidance you need to own your future success. Together, we can transform healthcare.

　　The Director of Regulatory Affairs for Digital Technologies will lead the Regulatory team for Medtronic’s Digital Technologies Business Unit, which is part of the Surgical Operating Unit.

　　This role oversees the Regulatory team within the Surgical OU responsible for bringing new digital health products to market, including Software as a Medical Device (SaMD), Artificial Intelligence/Machine Learning (AI/ML) enabled devices, and software as part of a medical device.

　　The Director of Regulatory Affairs will work closely with internal and external partners and ensure key milestones are met. The role will require strong working relationships with colleagues across the organization, and with regulators, including FDA and NBs as well as industry groups. This role requires experience with premarket regulatory activities in the US, EU and other global markets.

　　This role reports to the Vice President, Regulatory Affairs for the Surgical Operating Unite and leads a team of regulatory professionals responsible for obtaining new product approvals.

　　A Day in the Life

　　Responsibilities may include the following and other duties may be assigned.

　　Develops and leads strategies that provide a competitive advantage in global markets with earliest possible approvals of new product development.

　　Partners with innovation leaders to support execution of regulatory strategy, provides guidance and ensures compliance with regulatory requirements.

　　Establishes organization goals and objectives and leads regulatory personnel. Champions engagement, inclusion, and diversity efforts as well as career development and performance management.

　　Directs or performs coordination and preparation of document packages for regulatory submissions from all areas of company, internal audits, and inspections.

　　Leads or compiles all materials required in submissions, license renewal and annual registrations.

　　Recommends changes for labeling, manufacturing, marketing, and clinical protocol for regulatory compliance.

　　Develop and maintain strong relationships with FDA and Notified Bodies.

　　Work with direct reports to develop successful regulatory strategies to ensure timely device approvals.

　　Support new venture initiatives and acquisitions/ integrations as needed.

　　Keeps abreast of regulatory requirements, procedures and changes.

　　Attract, hire and develop talent to build a strong regulatory team.

　　Act as Regulatory Affairs business partner to cross-functional colleagues.

　　Must Have: Minimum Requirements

　　Bachelors degree or equivalent experienceNice to Have

　　Strongly Preferred:

　　Strong regulatory experience with SaMD, Apps and software in medical device systems

　　AI/ML experience

　　US Regulatory experience, including PMA, DeNovo and/or 510(k) experience

　　EU Regulatory experience, including EU MDR and working with Notified Bodies

　　Broad regulatory experience pre- and post- market

　　International regulatory affairs

　　Advocacy, regulatory intelligence experience

　　Understanding of new product development process and clinical affairs (including leveraging of real world evidence)

　　Great collaboration and people management skills

　　About Medtronic

　　Together, we can change healthcare worldwide. At Medtronic, we push the limits of what technology, therapies and services can do to help alleviate pain, restore health and extend life. We challenge ourselves and each other to make tomorrow better than yesterday. It is what makes this an exciting and rewarding place to be.

　　We want to accelerate and advance our ability to create meaningful innovations - but we will only succeed with the right people on our team. Let’s work together to address universal healthcare needs and improve patients’ lives. Help us shape the future.

　　Executive Level Roles: Base pay is based on numerous factors and may vary depending on job-related knowledge, skills, and experience.

　　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. Learn more about our benefits here (http://benefits.medtronic.com/) .

　　MIP Eligible: This position is eligible for a short-term incentive plan. Learn more about Medtronic Incentive Plan (MIP) here .

　　LTI Eligible: This position is eligible for an annual long-term incentive plan. Learn more about Medtronic Long-Term Incentive Plan (LTIP) here .

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　　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.