Johnson & Johnson is seeking a Regulatory Affairs Leader for its Orthopaedics division in Tokyo, Japan. The role requires at least five years of experience in medical device regulatory affairs, focusing on strategic planning and execution of regulatory actions aligned with business goals
Job Summary
Johnson & Johnson MedTech operates multiple business areas including Orthopaedics, Surgery, Electrophysiology, and Neurovascular, and this position focuses on regulatory affairs within Orthopaedics.
The role involves planning, preparing, and executing regulatory actions aligned with business strategies to achieve business goals, including regulatory submissions and negotiations with PMDA and other authorities.
Following the planned separation of the Orthopaedics business into DePuy Synthes, the employee will transition to DePuy Synthes with employment governed by their policies and benefits.
Matching Summary
Match Score: 85
Johnson & Johnson is seeking a Regulatory Affairs Leader for its Orthopaedics division in Tokyo, Japan. The role requires at least five years of experience in medical device regulatory affairs, focusing on strategic planning and execution of regulatory actions aligned with business goals.
Skills & Requirements
Must-have
Medical device regulatory affairs
Orthopaedics product regulatory management
PMDA regulatory negotiation
English communication with overseas manufacturers
Regulatory submission execution
Change management for marketed products
Nice-to-have
Leading PMDA pre-consultations
Supporting and mentoring team members
Compliance with pharmaceutical laws
Cross-functional project participation
Experience with medical device clinical trial consultations
Key Requirements
At least 5 years medical device regulatory experience
Experience with Class II or higher medical devices
English proficiency for document comprehension and communication
Master’s degree or higher in engineering, science, pharmacy, medicine, or related fields