Sr. Director, Quality Assurance and Regulatory Affairs (QARA) Endoscopy

Covidien Japan Inc • Lafayette, CO

227d • $217,600 - $366,000

About The Position

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.

Requirements

• Bachelor's degree in Engineering, Life Sciences, Regulatory Affairs, or related field.
• 15+ years of relevant progressive experience in Quality Assurance and Regulatory Affairs within the medical device industry or an advanced degree with a minimum of 13 years of relevant progressive experience.
• 10+ years of people leadership, including global team management.
• Demonstrated experience with FDA, EU MDR, and global regulatory submissions and inspections.

Nice To Haves

• Advanced degree (MS, PhD, RAC certification, or MBA).
• Experience working in a global matrixed MedTech organization.
• Knowledge of gastrointestinal diagnostics or endoscopy.
• Strong communication, leadership, and cross-functional collaboration skills.
• Understanding of Medical AI fundamentals and its application in diagnostics and clinical decision support.
• Familiarity with evolving regulatory landscapes, especially FDA requirements related to AI.

Responsibilities

• Lead a global organization of ~3-4 direct reports including Global QA Director, Global RA Director, Regional Quality Managers, and specialized functional leaders.
• 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.
• 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.
• Develop and implement OU Quality strategy and plans that drive significant improvements, 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.
• Establish quality metrics and drive a culture of accountability, inspection readiness, and operational excellence.
• Partner with R&D, Clinical, Operations, and Marketing to influence product development and commercialization strategies from a regulatory and quality perspective.

Benefits

• Health, Dental and vision insurance.
• Health Savings Account.
• Healthcare Flexible Spending Account.
• Life insurance.
• Long-term disability leave.
• Dependent daycare spending account.
• Tuition assistance/reimbursement.
• Incentive plans.
• 401(k) plan plus employer contribution and match.
• Short-term disability.
• Paid time off.
• Paid holidays.
• Employee Stock Purchase Plan.
• Employee Assistance Program.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Education Level: Bachelor's degree