We anticipate the application window for this opening will close on - 21 Feb 2026

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

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.

Cardiac Ablation Solutions (CAS) is one of the Operating Units within the Cardiac portfolio at Medtronic. At CAS we are developing next generation medical technologies that treat patients with abnormal heart rhythms. Our technologies save lives and improve the quality of living for millions of patients across the world by advancing innovation for the diagnosis and ablation of cardiac arrhythmias and enabling clinicians to perform procedures with superior outcomes.

The CAS business is projected to have solid growth and this role will be critical in enabling our business to achieve our objectives to drive innovation accelerate product introduction and lead the adoption of CAS driven therapies in the this role as the Sr Director of Regulatory Affairs you will lead a team of regulatory affairs professionals for the Affera platform. This role requires a combination of deep regulatory experience compliance expertise technical aptitude and business acumen. It will be critical that the candidate for this role be able to demonstrate an ability to work effectively with FDA and EU notified bodies on Class III products implement regulatory strategies and maintain compliance. Ability to lead and motivate a team while building strong global relationships both cross-functional and with global internal and external regulatory partners. Interpret regulatory requirements and effectively communicate internally with cross functional leadership.

At Medtronic we bring bold ideas forward with speed and decisiveness to put patients first in everything we -person exchanges are invaluable to our work. Were working a minimum of 4 days a week onsite as part of our commitment to fostering a culture of professional growth and cross-functional collaboration as we work together to engineer the extraordinary.

Responsibilities may include the following and other duties may be assigned.

• Provide strategic regulatory guidance to business leadership.

• Develops and implements strategies to achieve timely global commercialization of products in compliance with applicable regulations and standards.

• Ensures comprehensive and compliant support of released products and support internal and external audits.

• Develops and maintains ongoing relationships with global regulatory partners and regulatory authorities.

• Establishes and maintains internal controls to ensure compliance as required by regulatory authorities.

• Partners across the business and enterprise to continually improve processes related to regulatory activities.

• Leads a strong diverse regulatory affairs team with the competencies required to support a global portfolio in an evolving regulatory landscape.

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

• Demonstrate an ability to leverage learning and experience therapy-to-therapy in gaining approvals and maintaining approved status.

• Review advertising and promotional materials

Must Have: Minimum Requirements

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

• Bachelors degree in scientific/technical field required; (or for degrees earned outside of the United States a degree which satisfies the requirements of 8 C.F.R. 214.2(h)( 4)(iii)(A) and minimum 15 years prior experience in regulatory affairs clinical quality and/or product development

• With Masters or other advanced degree minimum 13 years prior experience in regulatory affairs clinical quality and/or product development

• Minimum of 10 years of managerial experience

Nice to Have

• 10 years of Regulatory Affairs experience preferred ideally in the cardiovascular space. Experience in other related functions such as clinical quality or product development may be considered

Regulatory / Compliance Expertise

• Extensive regulatory knowledge and experience across a wide variety of product classifications; including higher classification devices (i.e. Class III PMA Class III EU).

• Management of a large global product portfolio with a demonstrated ability to manage a wide array of simultaneous activities

• Ability to apply experience to develop complex strategies

• Ability to build and leverage expertise across the bread the of the Medtronic enterprise regulatory function(s)

• Experience in impactful negotiations with regulatory agencies

• Deep knowledge of pre- and post-market compliance requirements

• Experience partnering across functions on advertising and promotional activities

Technical aptitude

• Background in a scientific or other technical discipline

• Excellent problem-solving skills and an ability to apply critical thinking

• Knowledge of product development processes and tools

• Application of significant working knowledge of other functional areas to identify and execute on opportunities for improvement

Business acumen

• Significant experience as a member of senior business leadership teams

• Demonstrated ability to partner to resolve complex business challenges

• Ability to apply domain expertise and knowledge of regulatory environment to advise business on appropriate actions and future direction

• Influences across functions and businesses to negotiate and gain cooperation on divergent objectives.

• Competency in management of departmental budget

Communication / Leadership Skills

• Demonstrated ability to develop and maintain strong impactful relationships with global regulators

• Ability to clearly articulate a complex strategy

• Collaboration skills to partner with other functions to develop efficient approval strategies and resolve complex issues

• Confidence and impact in presenting to diverse audiences

• Ability to lead a team of experienced regulatory staff with responsibility for organizational structure and talent strategy ensuring skillsets evolve to meet the needs of the global regulatory landscape

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):$221600.00 - $332400.00

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 addition Medtronic will provide reasonable accommodations for qualified individuals with disabilities.