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

Job Details

Location: Japan
Salary: Negotiable
Job Type: Permanent
Specialization: Pharmaceutical & Medical Device, Legal & Compliance
Reference: BBBH46372_1698884171

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.

If this position is not ideal for you, but you are looking for a new opportunity,please contact us to discuss your options.

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