Senior Principal Regulatory Affair Specialist

About this role

Careers that change lives start here. Medtronic is a global leader in healthcare technology with a Mission to alleviate pain, restore health, and extend life. Our 95,000 employees work across more than 150 countries to put patients first — developing innovative medical technologies that improve the lives of 72+ million patients each year. Your unique talents will help shape the future of healthcare while building a career grounded in purpose, growth, and impact.

A Day in the Life At Medtronic, we bring bold ideas forward with speed and decisiveness to put patients first in everything we do. This position is remote to enhance our competitive edge and expand our cross-functional collaboration efforts. This role will require 10% of travel to enhance collaboration and ensure successful completion of projects.                    

The Senior Principal Regulatory Affairs Specialist serves as the regulatory lead for the review of advertising and promotional materials across the ICT product portfolio. This role is responsible for ensuring that all externally facing promotional content is accurate, compliant with applicable regulatory requirements, and aligned with internal policies and business objectives. The position requires close cross-functional collaboration with Marketing, Legal, Clinical, Medical, Quality, and other relevant stakeholders to coordinate efficient review cycles and support timely material approvals. The Senior Principal RAS acts as a key advisor on regulatory requirements, provides clear guidance to internal partners, and helps manage stakeholder expectations throughout the review process. Responsibilities also include keeping senior management informed of the regulatory status of products and significant regulatory issues while continuously maintaining proficiency in global regulatory requirements. 

Role And Responsibilities:   • Develop and support global regulatory strategies for Class I, II, and Class III therapy and diagnostic devices and the relevant accessories.  • 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 and PMA and PMA supplements or 510(k) submissions for new products and product changes as required to ensure timely approvals to support clinical studies and market releases.  • Negotiate with regulatory authorities to resolve questions/issues that arise prior to and during product submissions.  • Interact directly with major market regulatory agencies in support of product registration, approval, and commercialization.  • Participate in product change assessments and define the regulatory impact of product changes in global markets.  • Provide support to market-released products. This includes reviewing labeling, product changes, manufacturing site transfer activities and documentation for changes requiring government approval.  • Establish and maintain good relationships with agency personnel.  • Collaborate with International RAS to understand worldwide regulatory requirements to enable the development of strategies and requirements for global commercialization.  • Develop options of regulatory strategies, risks mitigation, issues and submission decisions/content and provide recommendations to the manager for decisions based on business impact.  • Ensure personal understanding of all quality policy/system items that are personally applicable.  Follow all work/quality procedures to ensure quality system compliance and high-quality work. 

Must-Have: Minimum Requirements   To be considered for this role, please ensure the minimum requirements are evident in your applicant profile. • Bachelor’s degree required.  • Minimum of 10 years of medical device regulatory affairs experience, or advanced degree with a minimum of 8 years of medical device regulatory affairs experience 

Nice to Have • Proven expertise in all aspects of Regulatory Affairs; Strategy Planning, US and major market regulatory requirements, project management, and negotiations  • Solid understanding of manufacturing and change control, and an awareness of regulatory trends  • Advanced degree in a scientific discipline (engineering, physical/biological or health sciences).  • Ability to comprehend principles of engineering, physiology and medical device use.   • Good analytical and critical thinking skills.  • International regulatory agency requirements, ISO I GHTF standards  • Experience performing advertising and promotion reviews for medical devices  • Product development experience 

For Baccalaureate degrees earned outside of the United States, a degree that satisfies the requirements of 8 C.F.R. § 214.2(h)(4)(iii)(A) is required.

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.

U.S. Work Authorization & Sponsorship At Medtronic, we are

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