We anticipate the application window for this opening will close on - 15 Jun 2025

 

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

Join us at Medtronic, where we are partnering across the industry to tackle systemic healthcare challenges with bold leadership. If you seek a challenging, energizing, and rewarding career that changes lives, we invite you to join our team. Become part of the next generation of life-changing medical technology, impacting patients worldwide.

Medtronic's Endoscopy Operating Unit (OU) is seeking a strategic and accomplished Sr. Director of Quality Assurance and Regulatory Affairs (QA/RA) to lead and evolve the global quality and regulatory function. This individual will be responsible for overseeing all aspects of quality compliance, regulatory strategy, product approvals, and post-market surveillance across a rapidly growing and innovative portfolio of GI solutions.

As a core leadership member of the Endoscopy OU, as well as other functional leadership teams, this role ensures the organization meets global regulatory requirements, delivers high-quality products, and maintains a robust culture of compliance, continuous improvement, and patient safety. This position is ideal for a mission-driven leader with deep regulatory and quality expertise, business acumen, and a passion for driving results in a highly matrixed, fast-paced environment.

This position reports to the Endoscopy Operating Unit President and will be based in Lafayette, CO, Santa Clara, CA or Minneapolis, MN. This position is on-site 4+ days/week.

As Sr. Director of Quality Assurance and Regulatory Affairs – Endoscopy, your leadership will ensure that patients receive safe, effective, and compliant products, enabling earlier diagnosis and better outcomes for those suffering from gastrointestinal conditions.

Key Responsibilities are:

Team Leadership & Organizational Development

• Lead a global organization of ~3-4 direct reports including Global QA Director (TBD) , Global RA Director (TBD); Regional Quality Managers, and specialized functional leaders; QA and RA specialists (with regional/global expertise)

• Build organizational capability through mentoring, succession planning, and professional development while fostering a culture of continuous improvement and regulatory excellence

• Establish clear performance metrics, develop team capabilities, and implement strategies to attract, retain, and grow top talent in quality and regulatory disciplines

• Build strong regulator relationships

Regulatory Affairs Leadership experience

• Develop and execute global regulatory strategies to support product approvals, new market entries, and portfolio expansion.

• Ensure timely and high-quality regulatory submissions and interactions with global health authorities.

• Deeply understands and can articulate how regulatory creates value

• Translate scientific information to regulatory strategy

• Serve as the primary regulatory advisor to cross-functional teams and executive leadership.

• Experience across a range of geographies and device risk classifications

• Experience leading through challenging situations (e.g., Warning Letter remediation)

Quality Assurance Leadership experience

• Develop and implement OU Quality strategy and plans that drive significant improvements, and are aligned with OU, Region, GOSC Quality and Enterprise strategic priorities.  

• Responsible for the global quality system (QMS) for Endoscopy, ensuring compliance with ISO, FDA, and other international regulatory standards.

• Lead quality initiatives to support product lifecycle management, manufacturing scale-up, and continuous improvement ensuring the highest reliability in new product introduction programs according to DRM principles.

• Establish quality metrics and drive a culture of accountability, inspection readiness, and operational excellence.

• Direct the internal and external audit program within Endoscopy, ensuring inspection readiness, managing notified body relationships, and overseeing successful regulatory agency inspections

Strategic & Cross-Functional Collaboration

• Partner with R&D, Clinical, Operations, and Marketing to influence product development and commercialization strategies from a regulatory and quality perspective.

• Collaborate with regional QA/RA teams to en