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