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. Youll 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.

Medtronics 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 ensure alignment and consistency in quality and regulatory practices worldwide.

• Collaborate with enterprise and regional Quality and Regulatory teams as well as GOSC Quality.

Medtronic Mindset Expectations

As a Medtronic leader you are expected to exemplify and inspire the Medtronic Mindset:

• Act Boldly: Embrace innovation while maintaining the highest standards of compliance and integrity.

• Compete to Win: Lead a high-performing QA/RA function that enables market access and product differentiation.

• Move with Speed and Decisiveness: Ensure responsive regulatory strategies and proactive quality actions.

• Foster Belonging: Lead inclusively developing talent and building strong diverse teams.

• Deliver Results the Right Way: Champion ethical conduct and decision-making across all quality and regulatory activities.

Must Have: Minimum Requirements

To be considered for this role please ensure the minimum requirements and your permanent address are evident on your resume.

• Bachelors 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 in Quality Assurance and Regulatory Affairs within the medical device industry.

• 10 years of people leadership including global team management.

• Demonstrated experience with FDA EU MDR and global regulatory submissions and inspections.

Nice to Have

• 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 how AI is applied in areas like diagnostics clinical decision support imaging etc.

• Familiarity with evolving regulatory landscapes especially FDA requirements related to AI.

• Awareness of the AI lifecycle including risks like bias drift and overfitting.

• Ability to navigate uncertainty building regulatory strategies to manage AI-related risks and ensure compliance.

*Salary Ranges for US locations in Lafayette CO and Minneapolis MN (USD): $217600.00 - $326400.00.00

**Salary Ranges for US locations in Santa Clara CA (USD): $244000.00 - $366000.00

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.

The physical demands described within the Responsibilities section of this job description are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. For Office Roles: While performing the duties of this job the employee is regularly required to be independently mobile. The employee is also required to interact with a computer and communicate with peers and co-workers. Contact your manager or local HR to understand the Work Conditions and Physical requirements that may be specific to each role.

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.

Salary ranges for U.S (excl. PR) locations (USD):$244000.00 - $366000.00

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.

The base salary range is applicable across the United States excluding Puerto Rico and specific locations in California. The offered rate complies with federal and local regulations and may vary based on factors such as experience certification/education market conditions and location. Compensation and benefits information pertains solely to candidates hired within the United States (local market compensation and benefits will apply for others).

The following benefits and additional compensation are available to those regular employees who work 20 hours per week: Health Dental and vision insuranceHealth Savings AccountHealthcare Flexible Spending AccountLife insurance Long-term disability leaveDependent daycare spending accountTuition assistance/reimbursement andSimple Steps (global well-being program).

The following benefits and additional compensation are available to all regular employees:Incentive plans 401(k) plan plus employer contribution and matchShort-term disabilityPaid time offPaid holidaysEmployee Stock Purchase PlanEmployee Assistance ProgramNon-qualified Retirement Plan Supplement (subject to IRS earning minimums) andCapital Accumulation Plan (available to Vice Presidents and above or subject to IRS earning minimums).

Regular employees are those who are not temporary such as interns. Temporary employees are eligible for paid sick time as required under applicable state law and the Employee Stock Purchase Plan. Please note some of the above benefits may not apply to workers in Puerto Rico.

Further details are available at the link below:

Medtronic benefits and compensation plans

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.

It is the policy of Medtronic to provide equal employment opportunity (EEO) to all persons regardless of age color national origin citizenship status physical or mental disability race religion creed gender sex sexual orientation gender identity and/or expression genetic information marital status status with regard to public assistance veteran status or any other characteristic protected by federal state or local law. In addition Medtronic will provide reasonable accommodations for qualified individuals with disabilities.