We anticipate the application window for this opening will close on - 30 May 2026

 

At Medtronic you can begin a life-long career of exploration and innovation, while helping champion healthcare access and equity for all. You’ll lead with purpose, breaking down barriers to innovation in a more connected, compassionate world.

A Day in the Life

         

         

 Across our global Neuroscience organization, we advance care for some of medicine’s most complex neurological and spinal conditions. By combining innovative technology, data-driven insights, and deep clinical expertise, we partner with physicians and health systems to improve how patients are treated and supported throughout their care journey.

Our Neuromodulation Operating Unit provides advanced therapies for chronic pain, movement disorders, and other neurological conditions. Through spinal cord stimulation, deep brain stimulation, and targeted drug delivery systems, we deliver personalized treatments that restore function, reduce symptoms, and improve quality of life worldwide.

Check us out on LinkedIn: Medtronic Brain Modulation and Pain Interventions

The Principal Regulatory Affairs Specialist (Pr. RAS) is responsible for developing Class II and Class III medical device regulatory strategies and preparing US and worldwide product submissions to introduce products and changes to the market. The Pr. RAS also supports marketed product activities, including the development of advertising and promotional materials, license maintenance, annual reports, renewals, design/manufacturing change notifications, QMS audits, and manufacturing site registrations. 

 

At Medtronic, we bring bold ideas forward with speed and decisiveness to put patients first in everything we do. In-person exchanges are invaluable to our work. We’re 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.

  

Overview of Role

• Ability to travel periodically to a design site in the US for in-person collaboration with development teams.
• Prepare and support US, EU, and Canadian submissions and reviews, and support international submission reviews for new products and product changes to ensure timely market release approvals.  Interact directly with FDA and/or indirectly with international regulatory agencies on most projects at the reviewer level and resolve submission issues with internal cross-functional team members, Medtronic geography regulatory partners, and regulatory agencies as needed.
• Lead and execute regulatory strategies/plans and provide regulatory compliance requirements in support of cross-functional product development and product change teams.
• Find, interpret, and apply regulations and guidance appropriately for situations.
• Provide regulatory support for currently marketed products. This includes reviewing changes to existing devices, labeling, and other documentation. Prepare submissions and reports for regulatory agencies, as required.
• Collaborate with Marketing and Medical Education teams to develop and maintain advertising, promotion, and educational materials.
• Support regulatory compliance activities, including manufacturing site registration, audits, post-market vigilance reporting, product recalls, etc., as needed.
• Review significant regulatory issues with supervisor, as necessary, and work under general supervision following established procedures. Independently develop and determine a regulatory approach.
• Keep current on global directives, harmonized standards, and procedures, and communicate changes that may affect cross-functional areas.
• Ensure personal understanding of all quality policy/system items that are personally applicable.  Follow all work/quality procedures to ensure compliance with the quality system and high-quality work.
• Provide training and support for other members of the department. May mentor or supervise other RAS, as directed by the manager.
• Other tasks, as required.

Must