Director, Quality & Regulatory - MiniMed

IMM Medtronic Minimed India Private Limited; Schweinheim; Vor Ort; EUR 100.000 - 130.000; Vollzeit

Zusammenfassung

A leading global healthcare company in Schweinheim seeks an experienced Quality & Regulatory Affairs Director for their Diabetes business. The role involves leading the global QARA strategy, ensuring compliance with ISO standards, and overseeing post-market performance. The ideal candidate will have extensive experience in the medical device sector, strong leadership skills, and the ability to collaborate cross-functionally. Join the mission to improve healthcare access and equity worldwide.

Leistungen

Competitive salary

Flexible benefits package

Short-term incentive plan

Qualifikationen

• 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 and complaints handling.

Aufgaben

• Lead global Quality and Regulatory strategy for the Diabetes portfolio.
• Ensure compliance with ISO 13485, MDR, MDSAP, and other standards.
• Oversee complaints handling and CAPA processes across all regions.

Kenntnisse

Quality leadership

Regulatory affairs

ISO standards knowledge

Cross-functional collaboration

Post-market surveillance

Auditing skills

Strong communication

Ausbildung

Bachelor’s degree in Engineering, Life Sciences, or related field

Advanced degree preferred

Jobbeschreibung

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.

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.

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.