Director, Regulatory Affairs & QA (Med Device) 品質保証・規制担当ディレクター
Location: Tokyo 東京
Industry: Medical Device 医療機器
We are recruiting for the position of Director of Regulatory Affairs and Quality Assurance in the Medical Device / Healthcare sector in Japan.
This is a chance to take a leadership role at a major Japanese company, with direct strategic impact. You will manage staff & oversee regulatory compliance / quality standards.
- Lead & manage teams responsible for regulatory submissions and quality audits.
- Manage compliance with Japan's Pharmaceutical and Medical Devices Agency (PMDA) regulations.
- Implement quality assurance procedures in line with Japanese Industrial Standards (JIS).
- Coordinate with regulatory agencies in Japan for approvals and submissions.
- Evaluate and update regulatory strategies based on industry trends and regulations.
- Significant experience in Regulatory Affairs and Quality Assurance within the Medical Device industry.
- In-depth knowledge of PMDA guidelines and JIS standards for medical devices.
- Proven leadership ability.
- Fluency in Japanese is mandatory.