The Senior Regulatory Affairs Specialist will provide strategic leadership for regulatory affairs in support of new product development and introduction within Medtronic’s Interventional Cardiology Therapies operating unit. The role supports the Research and Development programs with early phase pre-market regulatory strategy development with a view through the full product lifecycle. This role is responsible for shaping and executing global regulatory strategies, with a strong focus on pre-market submissions and early engagement with the global regulatory partners and/or regulatory authorities, as appropriate, across the United States, European Union, China, Japan, and Australia. The individual will serve as a subject matter expert on regulatory pathways for both hardware and software-based technologies, ensuring compliance and facilitating timely approvals to bring innovative products to market. Additionally, the individual in this role is expected to play a key role in the mentoring of junior team members and to be an active participant in the development and training of the Regulatory Affairs team. The individual will work in collaboration with Regulatory Affairs and cross functional members at varying levels within the organization. Strategic direction is expected to support a number of regulatory applications which may include, FDA Pre-submissions, PMDA consultations, original IDEs and PMAs, IDE and PMA Supplements/Reports, Shonin applications, China PTR submissions, and EU MDR Technical Documentation. The successful candidate will also actively support advertising and promotion activities for commercial products across the Interventional Cardiology Therapies portfolio, may support audit and compliance activities as needed and support business development activities/needs as they arise.  

Role and Responsibilities  

• Develop and execute global regulatory strategies for new product development and introduction, including software-based solutions and hardware.  

• Advise cross-functional teams on regional regulatory requirements, including FDA (US), EU MDR, NMPA (China), PMDA (Japan), and TGA (Australia).  

• Identify and recommend optimal regulatory pathways (e.g., 510(k), PMA, IDE, CE Mark, EU Technical Files, EU Design Dossiers, China NMPA registration, Japan PMDA Shonin, Australia TGA conformity assessments).  

• Lead regulatory risk assessments during product design and development, providing solutions to minimize approval delays.  

• Author, review, and lead global pre-market regulatory submissions.  

• Drive regulatory agency interactions, including FDA Pre-Sub meetings, Notified Body consultations, PMDA pre-consultations, and Scientific Advice processes.