Full-Time

Director - Quality & Regulatory

Minimed

Posted on 12/13/2025

Medtronic

Medtronic

10,001+ employees

Medical device maker advancing therapies

No salary listed

London, UK + 4 more

More locations: Paris, France | Sydney NSW, Australia | Minna, Inverin, Co. Galway, Ireland | Neukirchen-Vluyn, Germany

In Person

Category
Legal & Compliance (1)
Requirements
  • 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
Responsibilities
  • 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
Desired Qualifications
  • 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

Medtronic makes medical devices and therapies to treat chronic diseases, including implantables, sensors, and diabetes management tools. Its devices interact with the body to regulate or monitor functions, such as pacemakers delivering heart stimulation and neuromodulation devices sending electrical signals. The company differentiates itself through a long history of device development and a broad portfolio, expanded via acquisitions to access new technologies and markets. Its goal is to improve patient health outcomes by providing integrated medical technologies that help manage chronic conditions.

Company Size

10,001+

Company Stage

IPO

Headquarters

Fridley, Minnesota

Founded

1949

Simplify Jobs

Simplify's Take

What believers are saying

  • MiniMed separation could unlock value for Medtronic's diabetes business.
  • Galway software hub strengthens cloud-based cardiac monitoring and clinical software capabilities.
  • SPR Therapeutics adds temporary peripheral nerve stimulation to neuromodulation.

What critics are saying

  • Electrophysiology rivals can steal physician adoption from Medtronic's ablation growth engine.
  • Tariff costs already pressure fiscal 2027 margins and earnings.
  • MiniMed IPO execution will expose diabetes franchise weakness if pricing disappoints.

What makes Medtronic unique

  • 1949 garage roots produced Medtronic's first wearable, battery-powered pacemaker.
  • Acquisitions, especially Covidien in 2015, transformed Medtronic into a broad-device platform.
  • Cardiac ablation reached a $2 billion annualized run rate in fiscal 2026.

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Benefits

Health Insurance

Dental Insurance

Vision Insurance

Life Insurance

Disability Insurance

Health Savings Account/Flexible Spending Account

Unlimited Paid Time Off

Paid Vacation

Paid Sick Leave

Paid Holidays

401(k) Retirement Plan

401(k) Company Match

Employee Stock Purchase Plan

Employee Assistance Program

Wellness Program

Growth & Insights and Company News

Headcount

6 month growth

0%

1 year growth

0%

2 year growth

0%
Investing.com
Jun 3rd, 2026
Medtronic invests in two ICE catheter technology companies By Investing.com

Medtronic invests in two ICE catheter technology companies

Yahoo Finance
Apr 10th, 2026
GE HealthCare and Medtronic launch integrated neurosurgery imaging and navigation system

Medtronic and GE HealthCare have launched a digital integration combining GE's bkActiv intraoperative ultrasound with Medtronic's Stealth AXiS surgical navigation system for cranial neurosurgery. The commercially available system provides real-time imaging during procedures, connecting Medtronic's navigation and robotics platforms with GE HealthCare's imaging technology. The integration aims to enhance clinical decision-making during complex cranial procedures through precise guidance and visualisation. It may influence hospital equipment purchasing decisions, surgeon productivity and operating room efficiency. Medtronic currently trades at $87.91, approximately 19.8% below the $109.64 analyst target range midpoint. The stock has experienced a 2.2% decline over the past 30 days. Adoption rates amongst surgeons and hospitals, alongside hospital capital spending on neurosurgery suites, will be key factors to monitor.

The Associated Press
Apr 9th, 2026
GE HealthCare integrates bkActiv ultrasound with Medtronic Stealth AXiS for real-time cranial surgery navigation

GE HealthCare has announced a digital integration between its bkActiv intraoperative ultrasound system and Medtronic's Stealth AXiS surgical navigation system, now commercially available for cranial procedures. The integration allows neurosurgeons to use bkActiv as a plug-and-play real-time visualisation solution during procedures. The system addresses "brain shift", a natural movement of the brain during surgery that reduces pre-surgical image accuracy. bkActiv provides live ultrasound images alongside pre-operative MRI or CT scans on the Stealth AXiS system, recently cleared by the FDA for cranial procedures in the United States. Features include sterilisable transducers, sensitive colour Doppler for blood flow visualisation, and remote control capability from the sterile field. The companies will showcase the integration at the American Association of Neurological Surgeons Annual Scientific Meeting in May 2026.

Yahoo Finance
Apr 7th, 2026
Stifel cuts Medtronic price target to $95 from $105 on MiniMed IPO dilution

Stifel has lowered its price target on Medtronic (NYSE:MDT) to $95 from $105, maintaining a Hold rating. The adjustment reflects transaction-related impacts from the 9 March IPO of Medtronic's Diabetes business, now called MiniMed. MiniMed will remain a consolidated subsidiary until formal separation, expected about six months post-IPO. Stifel continues to model full Diabetes business revenue whilst adjusting for the 10% non-controlling interest sold in the IPO. Management expects IPO-related earnings per share dilution of 1-2 cents monthly until separation completes. Separately, the US Food and Drug Administration recently cleared Medtronic's Stealth AXiS surgical system for cranial and ear, nose and throat procedures, expanding beyond its earlier spine indication.

Silicon Republic
Apr 3rd, 2026
What impact might Medtronic's new lab have on Galway's medtech ecosystem?

What impact might Medtronic's new lab have on Galway's medtech ecosystem? 3 Apr 2026 From left: Ruth Callanan, Ronan Rogers and John Caulfield. Image: Andrew Downes/Xposure Ronan Rogers and Ruth Callanan discuss innovation in the west of Ireland and the evolution of Ireland's STEM careers. Ireland's medtech sector is moving beyond traditional biomedical engineering, according to Ronan Rogers, the senior R&D director for cardiac ablation solutions at Medtronic. He explained the region has built "real depth", not just in medtech, but across key areas such as pharmaceutical science, advanced analytics and digital technology. Areas that are now "increasingly converging". "That diversity of opportunity is a huge strength for Ireland," he told SiliconRepublic.com. "It allows people from different professional backgrounds to find meaningful, high-impact careers in healthcare, while helping Ireland move further up the value chain as a centre for complex, globally relevant innovation." Having recently expanded its Galway-based pharmaceutical laboratory, the Medtronic facility now serves as a west of Ireland hub for high-tech innovation and the evolving needs of the global healthcare space. Rogers is of the opinion that this is reflective of the convergence of the country's medtech divisions. Noting that the primary purpose of the lab "is to integrate pharmaceutical, engineering and analytical expertise under one roof to address the complex challenges of combination products, [that is] where a medical device and a medicine work together". "We see that convergence very clearly in this laboratory and there is a wide range of career paths in our industry, whether that's a pharmacist drawn to the faster innovation cycles and applied science of medtech, or a software developer who wants to use their skills to solve real healthcare challenges and code with a deeper sense of purpose." What opportunities exist? With the expansion comes the opportunity for students and professionals to consider a new role, either as part of Medtronic or within Galway's thriving life science and medtech spaces. "Galway offers a unique innovation ecosystem where infrastructure, academic partnerships and a significant medtech footprint all provide a strong foundation for sustaining Ireland's leadership in the life sciences sector," said Ruth Callanan, Medtronic's director of site quality. With the investment focused on significantly expanding R&D capability and technical depth within a critical space in the Irish medtech sector, Medtronic has increased lab space by almost a half and introduced analytical technologies that didn't exist there before. Callanan said: "This creates the conditions for future high-value work as programmes grow. It strengthens Galway's ability to attract and retain highly specialised talent, pharmaceutical scientists, chemical and materials engineers and it allows work that was previously outsourced internationally to be done here in Ireland. "Over time, as demand and activity scale, we do expect this capability to support additional specialist roles, phased in over the coming years. Importantly, it reinforces Ireland's position at the forefront of advanced medtech R&D and reflects a broader industry trend toward self-sufficiency in high-tech analytical testing." Step into the future. She explained the new lab will enable experts to integrate processes as the facility will be responsible for the entire life cycle of product development, from early phase R&D through to post-market oversight. She added: "The laboratory utilises advanced LCMS [liquid chromatography-mass spectrometry] and GCMS [gas chromatography-mass spectrometry] technologies, which act as 'molecular microscopes'. This allows our scientists to identify unknown compounds or impurities at extremely precise levels." According to Rogers, the new lab has a role to play in what he believes to be the reshaping of how STEM careers in Ireland are perceived and pursued, with Callanan noting this creates for students and professionals opportunities to engage with careers that bridge the gap between various scientific disciplines. "A laboratory of this size and complexity requires students and professionals with a wide range of skills and experience across multiple disciplines," she said. "Just as importantly," added Rogers, "we're sending a clear signal to pharmacists, chemists and analytical scientists that medtech offers deep, intellectually challenging career paths that go well beyond traditional manufacturing or even classical biomedical engineering." Laura Varley is the Careers editor for Silicon Republic

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