Director of Regulatory Affairs, JAPAC MedTech
Core
Strategic regulatory leader and trusted advisor for medical technology clients across Japan and the Asia-Pacific region, developing strategies for product development, market access, and commercialization.
Role type
Director of Regulatory Affairs (Client-facing Consulting)
Builds
Regulatory strategies, global registration programs, and market access solutions for medical devices, diagnostics, digital health, and SaMD.
Domain
MedTech / Life Sciences / Regulatory Affairs
Deliverable
client delivery
Required skills
Global regulatory strategy, multi-country submissions, FDA bridging, risk-based recommendations, project leadership, budget oversight, regulatory authority interactions, business development, team mentorship
Preferred skills
RAC certification, Master's/MBA, consulting experience
Technologies
PMDA, FDA, TGA, NMPA, MFDS, HSA frameworks
Responsibilities
Provide strategic regulatory guidance to clients; Develop and execute regulatory strategies for product registrations and lifecycle management; Lead complex regulatory programs including multi-country submissions; Serve as trusted advisor to senior stakeholders; Direct large-scale regulatory projects ensuring timely delivery; Lead interactions with regulatory authorities and support inspections; Partner with commercial teams to identify business opportunities; Drive operational excellence in regulatory processes; Mentor and develop regulatory professionals; Represent company at industry conferences
Seniority
Director, strategic leadership & client advisory
