Director, Quality & Regulatory - MiniMed at Medtronic-Switzerland

Heerlen, Limburg, Netherlands -

Full Time

Start Date

Immediate

Expiry Date

10 Feb, 26

Salary

0.0

Posted On

12 Nov, 25

Experience

10 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Quality Management, Regulatory Affairs, ISO 13485, MDR, MDSAP, 21 CFR 820, Post-market Surveillance, Complaints Handling, CAPA Management, Cross-functional Collaboration, Digital Enablement, Leadership, Coaching, Customer Focus, Risk Management, Audit Management

Industry

Medical Equipment Manufacturing

Description

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 Diabetes Operating Unit focuses on improving the lives of those within the global diabetes community. As a business, we strive to empower people with diabetes to live life on their terms by delivering innovation that truly matters and providing support in the ways they need it. We’re committed to meeting people with diabetes where they are in their journey, always with an aim to make their lives easier. Our portfolio of innovative solutions are designed to provide customers greater freedom and better health, helping them achieve better glucose control, while spending less time managing their disease. We are seeking an experienced and strategic Quality & Regulatory Affairs (QARA) Director to join our global Diabetes business. This role will provide leadership for our Quality and Regulatory function across EMEA, APAC, and the Americas, supporting a high-volume, consumer-scale product portfolio including insulin pumps, CGMs, infusion sets, and related accessories. The successful candidate will play a pivotal role in driving global compliance, post-market excellence, and customer-focused quality outcomes, while shaping the next chapter of our Quality organization as the Diabetes business prepares to become a stand-alone company. A day in the life: Lead global Quality and Regulatory strategy for the Diabetes portfolio, ensuring compliance with ISO 13485, MDR, MDSAP, 21 CFR 820, and other applicable standards. Own global post-market quality performance: oversee complaints handling, CAPA, vigilance, and field action processes across all regions, ensuring timely closure and effective feedback to design and manufacturing. Represent the company with regulators and Notified Bodies, leading audit preparation, hosting inspections, and managing responses to findings or observations. Partner cross-functionally with R&D, Operations, Regulatory Affairs, Supply Chain, and Commercial to ensure patient safety, compliance, and operational continuity. Drive harmonization and continuous improvement of global Quality Management Systems, focusing on simplicity, efficiency, and digital enablement. Provide leadership and coaching to regional QARA teams, fostering a culture of ownership, collaboration, and proactive compliance. Monitor regulatory and quality trends, shaping readiness for upcoming MDR/IVDR changes and regional market requirements. Champion the voice of the customer by linking post-market data and complaint trends to design improvements and patient experience. Must haves: Bachelor’s degree in Engineering, Life Sciences, or related technical field (advanced degree preferred). 10+ years’ experience in Quality and/or Regulatory leadership within a medical device organization. Proven experience managing Notified Body audits and interacting with global regulators. Demonstrated success in post-market surveillance, complaints handling, and CAPA management for high-volume or consumer-facing devices. Experience leading multi-region QARA organizations (EMEA, APAC, Americas). Strong knowledge of ISO 13485, ISO 14971, MDSAP, and MDR/IVDR. Track record of leading cross-functional quality initiatives with measurable business and compliance outcomes. Excellent communication and influencing skills across all organizational levels. Nice to haves: Experience in connected devices, SaMD, or digital health. Exposure to spin-offs, integrations, or QMS transformations. Knowledge of combination product regulations and interactions with pharmaceutical partners. Prior experience in diabetes care, wearables, or other high-volume consumer medtech segments. This position is an exciting opportunity to work with Medtronic's Diabetes business. Medtronic has announced its intention to separate the Diabetes division to promote future growth and innovation within the business and reallocate investments and resources across Medtronic, subject to applicable information and consultation requirements. This separation provides our team with a bold opportunity to unleash our potential, enabling us to operate with greater speed and agility. As a separate entity, we anticipate leveraging increased investments to drive meaningful innovation and enhance our impact on patient care. 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. This position is eligible for a short-term incentive called the Medtronic Incentive Plan (MIP). This position is eligible for an annual long-term incentive plan. 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. Learn more about our business, mission, and our commitment to diversity here 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. 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. That’s 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 will… 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, it’s 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 setting is 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. For updates on job applications, please go to the candidate login page and sign in to check your application status. If you need assistance completing your application please email AskHR@medtronic.com To request removal of your personal information from our systems please email RS.HRCompliance@medtronic.com

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Responsibilities

Lead global Quality and Regulatory strategy for the Diabetes portfolio, ensuring compliance with applicable standards. Oversee global post-market quality performance and represent the company with regulators and Notified Bodies.