Regulatory Affairs Senior Specialist / Principal – 循環器医療機器
Abbott Medical Japan
Tokyo, Japan
5+ years medical device regulatory experience
Class iii/iv medical device approval expertise
Pmda submission document preparation
This role leads regulatory affairs for Abbott Medical Japan's Class IV cardiovascular medical devices, driving product approvals and lifecycle compliance
Job Summary
This role leads regulatory affairs for Abbott Medical Japan's Class IV cardiovascular medical devices, driving product approvals and lifecycle compliance.
The successful candidate will act as a senior individual contributor, managing complex applications and coordinating between global teams and Japanese regulatory authorities like the PMDA.
The position offers significant autonomy to shape regulatory strategy while mentoring junior team members in a high-impact environment focused on advanced medical technology.
Matching Summary
This role leads regulatory affairs for Abbott Medical Japan's Class IV cardiovascular medical devices, driving product approvals and lifecycle compliance.
Skills & Requirements
Must-have
5+ years medical device regulatory experience
Class III/IV medical device approval expertise
PMDA submission document preparation
English business communication proficiency
Stakeholder management and coordination
Nice-to-have
Direct negotiation with regulatory authorities
Development of regulatory strategies
Handling complex or precedent-setting cases
Internal subject matter expert influence
Key Requirements
Bachelor's degree in science (Master's/PhD preferred)
Minimum 5 years hands-on medical device regulatory experience
Proven track record leading Class III/IV device submissions