The role involves planning, preparing, and executing regulatory actions to align with business strategy and achieve company goals
Job Summary
The role involves planning, preparing, and executing regulatory actions to align with business strategy and achieve company goals.
Candidates will build regulatory strategies for new product launches and negotiate with review agencies like PMDA to ensure timely approvals.
This position is part of a planned separation where the employee will eventually become an employee of the standalone orthopaedics company, DePuy Synthes.
Matching Summary
The role involves planning, preparing, and executing regulatory actions to align with business strategy and achieve company goals.
Skills & Requirements
Must-have
5+ years medical device regulatory experience
Class II or higher medical device expertise
English reading and communication skills
Nice-to-have
PMDA pre-submission consultation leadership
Team support and mentoring experience
Master's degree in life sciences
Key Requirements
Minimum 5 years medical device regulatory experience
English proficiency for document review and communication
Master's degree preferred in engineering, pharmacy, or medicine