We anticipate the application window for this opening will close on - 31 Mar 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

The Senior Principal Regulatory Affairs Specialist will play a key role in creating regulatory strategies and submissions to bring new robotic products to the global markets. This role will also work on new product development, as well as work on sustaining/post-market regulatory activities for Class II robotic devices. Devices that are part of the Robotics Surgical Technology Business are inclusive of hardware and software components.  The senior principal specialist will work directly with new product development and sustaining teams to develop the global regulatory strategy and support regulatory activities throughout the product lifecycle.  The senior principal specialist has primary responsibility for compliance with US and EU regulatory requirements and partners with the international regulatory affairs group to support regulatory submissions worldwide for Class II medical devices. This includes support of product changes to ensure that regulatory requirements continue to be met, documenting regulatory decisions, submissions to agencies, reviewing promotional materials, and ensuring that product technical documentation is current and accurate. Responsibilities are performed through the collaboration with various functions across the business unit, including but not limited to Regulatory Affairs, Research and Development, Clinical, Quality, and Marketing.

Responsibilities also include keeping senior management informed of the regulatory status of products and significant regulatory issues and maintaining proficiency in global regulatory requirements.  

The successful candidate will be able to deal with advanced concepts and undefined paths, work independently, develop new and creative regulatory strategies and work collaboratively within the Regulatory department and other business functions.

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

• Develop and support global regulatory strategies for Class II devices and accessories for robotic surgical application.
• Be an active member of the product development core teams and responsible for identifying submission deliverables, timelines, and strategic direction.  Reviews and approves technical documentation.
• Provide feedback and work with engineers and technical experts to resolve potential regulatory issues and questions from regulatory agencies and provide ongoing support to product development teams to assure timely resolution to regulatory issues and questions.
• Prepare FDA IDE submissions, DeNovo/510(k) submissions, or EU submissions for new products and product changes as required.
• Directly communicates with regulatory authorities to resolve questions/issues that arise prior to and during product submissions or other pertinent issues.
• Participate in the product change assessments and define the regulatory impact of product changes in global markets.
• Provide support to market released products as necessary. This includes reviewing labeling, product changes, and documentation for changes requiring regulatory approval.
• Keeps abreast of new and changing global regulatory requirements and keep the business informed of implications of changes
• Collaborate with International regulatory teams to understand worldwide regulatory requirements to enable the development of strategies and requirements for global commercialization. Interact directly with major market regulatory agencies in support of product registration, approval, and commercialization.
• Leads or performs coordination and preparation of document packages for global regulatory submissions, license renewals, internal & external audits and inspections.
• Recommends changes for labeling, manufacturing, marketing, and clinical protocol for regulatory compliance.
• Plays an active role in continuous improvement of regulatory processes for the Robotics Business Unit.

Must Have: Minimum Requirements

• Bachelor’s degree required
• Minimum of 10 years of relevant experience, or advanced degree with a minimum of 8 years of relevant experience.

Nice to Have

• Degree in Engineering
• Experience with US and EU submissions (e.g. 510(k), PMA, Pre-Sub, PCCP, IDE, MDR, etc.) with compl