Director, Regulatory Affairs & QA (Med Device) 品質保証・規制担当ディレクター

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.

Responsibilities:

• 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.

Qualifications:

• 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.