The role involves planning and executing regulatory actions to support business goals and achieve rapid product approvals from the PMDA
Job Summary
The role involves planning and executing regulatory actions to support business goals and achieve rapid product approvals from the PMDA.
Candidates must possess the ability to read English design documents from overseas manufacturers and communicate effectively with international stakeholders.
This position is part of a planned separation where successful candidates will eventually become employees of the standalone orthopaedics company, DePuy Synthes.
Matching Summary
The role involves planning and executing regulatory actions to support business goals and achieve rapid product approvals from the PMDA.
Skills & Requirements
Must-have
5+ years medical device regulatory experience
Class II or higher medical device expertise
English reading comprehension of design documents
PMDA negotiation and approval execution skills
Post-market change management procedures
Nice-to-have
Led PMDA pre-submission consultation meetings
Experience mentoring team members in regulatory affairs
Master's degree in engineering, pharmacy, or life sciences
Strong project leadership capabilities
Compliance with Pharmaceutical Affairs Law
Key Requirements
Minimum 5 years of Class II+ medical device regulatory experience
Advanced English proficiency for document review and communication
Master's degree preferred in engineering, pharmacy, or related field