The Principal Regulatory Affairs Specialist will provide strategic leadership for regulatory affairs in support of new product development and introduction within Medtronics Structural Heart & Aortic (SH&A) 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 Structural Heart & Aortic (SH&A) 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.

• Represent the company during negotiations and reviews with FDA Notified Bodies NMPA PMDA and TGA ensuring alignment on regulatory expectations.

• Represent the Regulatory Affairs function on product development teams bringing the voice of the function to discussions in an effort to support creative and compliant regulatory strategies for the program.

• Partner with cross-functional team members to lead engagements with regulatory agencies for new and existing devices.

• Lead and influence the preparation of documentation to support innovative and high-quality regulatory submissions from early phase strategies marketing applications and change management implementation.

• Engage and actively participate in compliance activities (preparation and execution) including identification of opportunities for improved efficiencies within processes.

• Act as a mentor to colleagues within the team and effectively manages an extended team.

• Stay current on regulation and guidance changes supporting advocacy work as needed to influence evolving regulatory requirements.

• Work with functional team members to ensure clear communication of project/program objectives deliverables and timing of key milestones.

• Partner in problem resolution in an effort to mitigate functional/ program level challenges to keep objectives moving in line with program estimates.

• Work within a matrixed collaborative team environment that fosters professional development while focusing on meeting business objectives driven by standards of excellence.

Must Have; Minimum Requirements

To be considered for this role please ensure the minimum requirements are evident in your applicant profile.

• Bachelors degree in a technical discipline

• Minimum of 7 years of direct Regulatory Affairs experience within the medical device or other regulated industry

• Or advanced degree with a minimum of 5 years of Regulatory Affairs experience.

• Medical device industry experience with Class I/II/III/IV software products.

Nice To Have:

• Direct Regulatory Affairs experience supporting programs throughout software development life cycle.

• Experience performing advertising and promotion reviews/approvals for medical devices.

• Experience in leading early interactions with regulatory authorities.

• Advanced degree in a scientific discipline (engineering physical/biological or health sciences).

• Working knowledge of Project Management methodologies and tools; PMP certification is an asset.

• Demonstrated strong business acumen and planning.

• Strong interpersonal quantitative analysis andproblem-solvingskills.

• High degree of initiative and influence management skills

• Results oriented. Ability to drive to completion in adherence to aggressive project schedules.

• Ability to manage multiple projects and proficiency with Microsoft Office and software tools.