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. Requirements 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) Core Competencies 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. Highest-signal resume keywords Regulatory Affairs Experience Medical Device Industry Knowledge Global Regulatory Strategy Development Regulatory Submissions Leadership Cross-Functional Team Collaboration ATS Optimization Keywords Hard Skills 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 Soft Skills Interpersonal Skills Influence Management Initiative Results Orientation Communication Certifications & Qualifications PMP Certification Industry Keywords FDA EU MDR NMPA PMDA TGA 510(k) PMA IDE CE Mark Medical Device Class I/II/III/IV Tools & Technologies Microsoft Office Regulatory Submission Tools Project Management Tools #J-18808-Ljbffr Jobtailor