5+ years medical device regulatory experience in japan
Expert knowledge of japanese pmda regulations
Class iii or iv product registration experience
This role offers the opportunity to drive regulatory strategy for innovative implantable hearing technologies in the Japanese market
Job Summary
This role offers the opportunity to drive regulatory strategy for innovative implantable hearing technologies in the Japanese market.
The successful candidate will lead submissions and compliance activities while acting as a key cross-functional link between regulatory, reimbursement, and quality systems.
Cochlear is dedicated to helping people with hearing loss experience a world full of sound through life-changing technologies.
Matching Summary
This role offers the opportunity to drive regulatory strategy for innovative implantable hearing technologies in the Japanese market.
Skills & Requirements
Must-have
5+ years medical device regulatory experience in Japan
Expert knowledge of Japanese PMDA regulations
Class III or IV product registration experience
Business level English writing and reading skills
High-level Japanese legal and technical terminology
Nice-to-have
Experience establishing Quality Management Systems
Willingness to manage long-term complex projects
Background in pharmacy, engineering, or science
Business level English speaking proficiency
Photoshop software proficiency
Key Requirements
Bachelor's Degree required
5 years minimum experience in Japan medical device RA
Expertise in Japanese Pharmaceutical and Medical Device Law