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