At Medtronic you can begin a life-long career of exploration and innovation while helping champion healthcare access and equity for all. Youll 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. Were 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:

• Bachelors 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 Medtronics 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.

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 95000 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