Director, QARA Japan

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Job Function:
Regulatory Affairs Group

Job Sub Function:
Regulatory Affairs

Job Category:
People Leader

All Job Posting Locations:
Chiyoda, Tokyo, Japan

Job Description:

DePuy Synthes is recruiting for a Director, QARA Japan, located in Chiyoda, Tokyo.

The Director, QARA Japan provides senior leadership for quality assurance and regulatory affairs for DePuy Synthes in Japan, one of the company's most complex and highly regulated markets.

This role is accountable for regulatory compliance, quality management system execution, and sustainable market access across the full product lifecycle.

This position plays a critical role in safeguarding patient safety while enabling innovation and business growth.

The Director partners closely with Japan country leadership, Global QARA, Commercial, Operations, Supply Chain, and Legal teams to manage regulatory and quality risk and to ensure successful product launches and ongoing compliance.

Key Responsibilities


* Lead and execute the Quality Assurance and Regulatory Affairs strategy for Japan in alignment with global QARA objectives and international business priorities.


* Ensure ongoing compliance with PMDA/MHLW requirements, applicable international standards, internal policies, and DePuy Synthes quality management system expectations.


* Provide strategic quality and regulatory guidance to support product registrations, renewals, variations, and full lifecycle management in Japan.


* Serve as the senior QARA escalation point for Japan, including direct engagement with health authorities and key external stakeholders as needed.


* Partner with cross‑functional stakeholders (Commercial, Operations, Supply Chain, Legal, and Global QARA) to support product launches, supply continuity, and portfolio optimization.


* Monitor, interpret, and communicate regulatory, quality, and enforcement trends in Japan, proactively assessing business and patient safety impact.


* Oversee and lead regulatory inspections, quality audits, and health authority interactions, ensuring timely, effective, and consistent responses.


* Drive continuous improvement, simplification, and h...