Senior Director, Regulatory Affairs, Robotics

Careers that Change Lives

A career at Medtronic is like no other. We're purposeful. We're committed. And we're driven by our Mission to alleviate pain, restore health and extend life for millions of people worldwide. We look for accountable leaders who have a clear vision of where we are going and how to get there, bold inclusive thinkers who create new ideas and bring our best solutions forward to benefit our patients, business partners, and customers.

We believe that when people from different cultures, genders, and points of view come together, innovation is the result -and everyone wins. Medtronic walks the walk, creating an inclusive culture where you can thrive.

Bring your talents to an industry leader in medical technology and healthcare solutions - we're a market leader and growing every day. You can be proud to be a part of technologies that are rooted in our long history of mission-driven innovation. You will be empowered to shape your own career. We encourage and support your growth with the training, mentorship, and guidance you need to own your future success. Together, we can transform healthcare.

The Senior Director of Regulatory Affairs will lead the Regulatory team for Medtronic's Robotic Surgical Business Unit (RST), which is part of the Surgical Operating Unit.

This role oversees the Regulatory team responsible for bringing Medtronic's Robotic technologies to market. It involves creating, managing and executing global regulatory strategies for new product development as well as sustaining existing products on the market. The role will require strong working relationships with colleagues across the organization, with regulators, including FDA, Notified Bodies as well as industry groups. This role requires strong experience with premarket regulatory activities in the US, EU and other global markets. This position will interact with global regulatory authorities and global regulatory personnel to facilitate successful product clearances/approvals and registrations worldwide. Specific experience in US IDE, 510(k), De Novo, and/or PMA submissions, EUMDR and global regulatory approvals is critical to the success of this position. As needed, due diligence and integration of potential acquisitions may also be required.

This role reports to the Vice President, Regulatory Affairs for the Surgical Operating Unit and will be responsible for leading, developing and mentoring a team of regulatory professionals.

The Robotic Surgical Business Unit (RST) is based in Boston, Massachusetts. The ideal candidate for this role will be based in Boston or eastern US with remote eligibility. Ability to travel to relevant sites (up to 25%).

The ideal candidate for this role will be based in Boston, MA, North Haven, CT or Lafayette, CO with remote eligibility. Ability to travel to relevant sites (up to 25%).

A Day in the Life

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

• Interface with Medtronic senior leadership on a regular basis, FDA, EU regulators, other regulatory authorities and consultants regarding regulatory submission strategy and approval reviews

• Provide leadership in the development of strategies to manage new, changing, and existing regulatory requirements

• Work with direct reports to develop successful global regulatory strategies to ensure timely device approvals. Oversee and manage regulatory compliance activities

• Provide management and leadership to the Regulatory Affairs organization in such areas as personnel, objectives, projects and responsibilities; contribute to the development and implementation of business strategic and operating plans

• Serve as a member of the Robotic Surgical Technology Business Unit's functional leadership team.

• Review submissions of regulatory staff and coach to ensure continuing development of regulatory skills

• Keep Senior Management informed of regulatory status of products and significant regulatory issues, and provide updates about new developments

• Direct submission negotiations with Notified Bodies, FDA, other regulators as deemed necessary, including pre-submission identification of requirements and strategy and post-submission negotiations to ensure timely approval

• Maintain proficiency on global regulatory requirements

• Provide strategic work direction, training, and regulatory advice to direct reports and other members of the regulatory department; interview and hire staff as necessary

• Conduct annual performance reviews; set objectives and foster professional development of staff

• Collaborate with R&D and Clinical to determine and execute pre-clinical/clinical test plans in support of regulatory submissions to adequately support global submissions

• Establish and maintain a professional and credible image with FDA, Notified Bodies, and other regulatory authorities

• Maintain superior knowledge of competitive technologies in addition to medical and technical developments related to the company's products

Must Have: Minimum Requirements

• Bachelor's degree

• Minimum of 15 years of Engineering, Regulatory, or Life Sciences experience with 10+ years of managerial experience, or Advanced Degree with a minimum of 13 years prior Engineering, Regulatory, or Life Sciences experience with minimum of 10 years of managerial experience

Nice to Have

• Proven experience with electromechanical medical device regulatory requirements and submissions, including software

• Exhibits comprehensive expertise in global regulations regarding the manufacture and distribution of medical devices

• Regulatory experience with robotic medical devices or devices with software

• Proven experience with developing robust global clinical and regulatory strategies

• Prior experience authoring and negotiating IDE, 510(k), De Novo and Technical Documentation

• Knowledge and experience with GCP, GLP and QMS

• Expertise in pre-clinical studies, clinical trial design, project management, and negotiations with regulators

• Ensures advertising and promotion of products conforms to the requirements of the specific market

• Excellent oral and written communication skills

• History of working collaboratively across functions

• Proven ability to comprehend anatomy & physiology, principles of engineering and the practice of electrosurgery

• Understanding of reimbursement requirements

• Experience working cross-culturally

About Medtronic

Together, we can change healthcare worldwide. At Medtronic, we push the limits of what technology, therapies and services can do to help alleviate pain, restore health and extend life. We challenge ourselves and each other to make tomorrow better than yesterday. It is what makes this an exciting and rewarding place to be.

We want to accelerate and advance our ability to create meaningful innovations - but we will only succeed with the right people on our team. Let's work together to address universal healthcare needs and improve patients' lives. Help us shape the future.

The provided base salary range is used nationally (except in certain CA locations). The rate offered is compliant with federal/local regulations and may vary by experience, certification/education, market conditions, location, etc.

Executive Level Roles: Base pay is based on numerous factors and may vary depending on job-related knowledge, skills, and experience

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. Learn more about our benefits here.

MIP Eligible: This position is eligible for a short-term incentive plan. Learn more about Medtronic Incentive Plan (MIP) here.

LTI Eligible: This position is eligible for an annual long-term incentive plan. Learn more about Medtronic Long-Term Incentive Plan (LTIP) here.

Physical Job Requirements

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. (ADA-United States of America)

EEO STATEMENT

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.

DISCLAIMER

The above statements are intended to describe the general nature and level of work being performed by employees assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties and skills required of employees assigned to this position.