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

Principal Regulatory Affairs Specialist – Global Regulatory Strategy and Advocacy position sits in the regulatory organization of Medtronic Diabetes and is charged with cross-functional collaboration to help build and advocate for innovative global regulatory strategies for next generation diabetes devices. These strategies will require a global mindset and critical thinking skills related to cutting edge regulatory topics such as digital health technologies like AI and SaMD to cybersecurity. In this role, you will work in a heavily matrixed environment consisting of specialists from every aspect of the device lifecycle.

Your work will be focused on supporting all activities to advance new product technologies from a regulatory perspective, which can include optimizing workflows and processes. This intersectionality provides an excellent entry point for those with experience in other areas of the medical device space who are looking to evolve their careers, including those with backgrounds in device advocacy, systems engineering, software design, cybersecurity, and/or quality assurance. This position is best suited for professionals desiring to develop their career in device innovation and digital health advocacy at the world’s leading medical device company.

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

• Develop and refine fit-for-purpose regulatory strategies to support innovations in the Diabetes business with stakeholders across the business—US, EU, international regulatory teams as well as from various partner functions such as quality assurance and R&D.
• Maintain proficiency of worldwide regulatory intelligence, including competitor filings, as part of developing innovative regulatory strategies.
• Establish advocacy channels and maintain good relationships with regulatory agency personnel, allies in industry, and advocacy organizations to promote our objectives in the global regulatory landscape.
• Manage projects assigned to support business improvement initiatives including process improvement and maintenance.
• Socialize strategies, advocacy efforts, and new learnings with our partners to resolve potential regulatory issues and questions that may arise from regulatory agencies to achieve desired results. All significant issues will be reviewed with the manager.
• Provide strategic input for preparation of submission packages (e.g. PMAs, 510k, Technical file dossiers, international submissions, etc.).
• Review of supporting documentation (e.g., labeling, design verification, clinical study design, etc.) to assure alignment with global regulatory strategy.
• Follow all work/quality procedures to ensure quality system compliance and high-quality work.
• Other duties as assigned.
• Remote work option available.
• Ability to travel, up to 10%, as business and local policies allow.

Must Have Qualifications

• Bachelors degree and a minimum of 7 years of regulatory experience within the medical device, biotech, or pharmaceutical industries
• Or, advanced degree and a minimum of 5 years of regulatory experience within the medical device, biotech, or pharmaceutical industries

Desired/Preferred Qualifications

• Master’s Degree or Doctorate in scientific/engineering fields and related medical device-oriented disciplines (e.g. Regulatory Affairs)
• Critical thinking and creative problem solving
• Technically savvy: must be able to discuss, understand and make decisions regarding a wide array of engineering disciplines and complex technical / logistical issues
• Clear communicator, able to break down highly technical information with stakeholders of various backgrounds and functional responsibilities to find a common understanding
• Experience in assembling facts from various areas, analyzing data, and providing informed recommendations
• Able to participate effectively in multiple workstreams with different goals and expectations. Capable of meeting the needs of teams in a timeline-dependent environment
• Experience with technical presentations and/or education sessions
• Product experience with software medical devices and quality systems
• Good working knowledge of FDA and international regulatory agency requirements, ISO/GHTF standards
• Experience with regulatory submissions, such as IDEs, Original PMAs, 510(k)s, 180 Days, Design Dossiers, Technical Files, 30-day Notices, and Real Time Reviews
• Regulatory Affairs Certi