Senior Regulatory Affairs Specialist

• 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.

• Bachelor’s degree in a technical discipline
• Minimum of 4 years of direct Regulatory Affairs experience within the medical device industry
• Or advanced degree with a minimum of 2 years of Regulatory Affairs experience within the medical device industry
• Medical device industry experience with Class I/II/III/IV software products
• Direct Regulatory Affairs experience supporting programs throughout software development life cycle (Nice To Have)
• Experience performing advertising and promotion reviews/approvals for medical devices (Nice To Have)
• Experience in leading early interactions with regulatory authorities (Nice To Have)
• Advanced degree in a scientific discipline (engineering, physical/biological or health sciences) (Nice To Have)
• Working knowledge of Project Management methodologies and tools; PMP certification is an asset (Nice To Have)
• Demonstrated strong business acumen and planning (Nice To Have)
• Strong interpersonal, quantitative analysis, and problem-solving skills (Nice To Have)
• High degree of initiative and influence management skills (Nice To Have)
• Results oriented (Nice To Have)
• Ability to drive to completion in adherence to aggressive project schedules (Nice To Have)
• Ability to manage multiple projects and proficiency with Microsoft Office and software tools (Nice To Have)

Demonstrates expertise in developing and executing global regulatory strategies for medical devices, including software-based solutions. Proficient in leading regulatory submissions and agency interactions while ensuring compliance with FDA, EU MDR, NMPA, PMDA, and TGA requirements.

• Regulatory Affairs Experience
• Medical Device Industry Knowledge
• Global Regulatory Strategy Development
• Regulatory Submissions Leadership
• Cross-Functional Team Collaboration

• Regulatory Strategy Development
• Regulatory Submissions
• Risk Assessment
• Regulatory Pathway Identification
• Advertising and Promotion Review
• Software Development Life Cycle
• Project Management Methodologies
• Quantitative Analysis
• Problem-Solving
• Regulatory Compliance

• Interpersonal Skills
• Influence Management
• Initiative
• Results Orientation
• Communication

• PMP Certification

• FDA
• EU MDR
• NMPA
• PMDA
• TGA
• 510(k)
• PMA
• IDE
• CE Mark
• Medical Device Class I/II/III/IV

• Microsoft Office
• Regulatory Submission Tools
• Project Management Tools