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. 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.