Director, QARA Japan (MedTech)

Location: Chiyoda, Tokyo, Japan; hybrid work

Company

Johnson & Johnson MedTech develops healthcare and medical device solutions, with this role supporting the DePuy Synthes orthopaedics business.

What you will do

• Lead the Quality Assurance and Regulatory Affairs strategy for Japan in alignment with global objectives and business priorities.
• Ensure compliance with PMDA/MHLW requirements, international standards, internal policies, and the DePuy Synthes quality management system.
• Guide product registrations, renewals, variations, launches, and full lifecycle management in Japan.
• Act as the senior QARA escalation point and engage with health authorities and external stakeholders.
• Partner with Commercial, Operations, Supply Chain, Legal, and Global QARA teams on launches, supply continuity, and portfolio optimization.
• Lead inspections, quality audits, continuous improvement initiatives, and the development of Japan QARA leaders and teams.

Requirements

• Bachelor’s degree in Regulatory Affairs, Life Sciences, Engineering, or a related discipline.
• 10–12 years of progressive Quality Assurance and/or Regulatory Affairs experience in medical devices or another highly regulated industry.
• Deep knowledge of Japanese regulatory requirements and PMDA/MHLW processes.
• Experience leading regulatory and quality strategy and execution in Japan and managing complex portfolios and risk.
• Experience working in a global, matrixed organization with senior stakeholders.
• Japanese and English are required. Moderate domestic and occasional international travel is expected.

Nice to have

• Advanced degree or professional certification in Regulatory Affairs, Quality, or a related field.
• RAC or equivalent certification.
• Experience with international QARA operating models, multinational medical device organizations, inspections, audits, health authority negotiations, or QARA transformation.
• Experience supporting diverse product portfolios across multiple therapeutic areas.

Culture & Benefits

• Inclusive work environment focused on employee dignity, diversity, and individual merit.
• Opportunity to support patient safety, healthcare innovation, and sustainable market access.
• Employment is currently with Johnson & Johnson; following the planned separation of the Orthopaedics business, it is anticipated that the role will transition to DePuy Synthes, subject to legal and regulatory approvals.