Sr. Director, RAQA - Japan
Core
Leading Regulatory Affairs, Quality Assurance, and Safety Control for the Japanese medical device market, ensuring compliance with PMDA/MHLW regulations and maintaining product safety standards.
Role type
Senior Director, Regulatory Affairs & Quality Assurance (Medical Devices)
Builds
Regulatory strategies, compliant Quality Management Systems (QMS), and safety management processes for medical devices.
Domain
Medical Devices / Regulatory Affairs / Quality Assurance / Japan
Deliverable
client delivery
Required skills
Regulatory strategy development, QMS implementation (ISO 13485), risk management, adverse event reporting, team leadership, stakeholder management, Japanese regulatory navigation (PMDA/MHLW)
Preferred skills
Master's degree in Life Sciences or Engineering, experience with FDA regulations, clinical program planning
Technologies
Regulatory submission software, Quality Management Systems
Responsibilities
Develop regulatory strategies for new product introduction and lifecycle management; oversee QMS audits and CAPA processes; manage safety reviews and adverse event reporting; recruit and mentor RA/QA/Safety teams; represent the company in regulatory inspections; assume Sokatsu-sekininsha responsibility under the J-PMD Act.
Seniority
Senior Director, strategic leadership & team management
