Sr. Director, RAQA - Japan

📋 Description

• Lead Regulatory Affairs, Quality Assurance and Safety Control in Japan
• Develop regulatory strategies for products and lifecycle management
• Ensure regulatory filings with PMDA/MHLW; manage inspections
• Oversee QMS aligned with ISO 13485; lead audits and CAPA
• Establish safety management, adverse event reporting, and field action processes
• Provide leadership to RA/QA/Safety teams and manage resources/budget

🎯 Requirements

• Master's degree or higher in a relevant field preferred
• 15+ years in medical device with RA/QA/Safety focus
• Experience as Sokatsu-sekininsha under J-PMD Act; PMDA/MHLW navigation
• Leadership track record; ability to build and mentor teams
• ISO 13485, FDA and global regulatory knowledge; clinical program planning
• Strong communication, collaboration, and analytical skills; English & Japanese fluency

🎁 Benefits

• On-site in Tokyo with defined schedule
• Competitive compensation aligned with role and candidate
• Opportunities for leadership growth and cross-functional collaboration