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 harmonization of QARA processes within the Japan market. 
• Lead, mentor, and develop Japan QARA leaders and teams, fostering a strong culture of quality, compliance, accountability, and performance. 
• Ensuring proactive engagement and shaping of regional policy initiatives that are critical to business strategy, continuity, and growth. 
   

Qualifications 

Education 

Required: Bachelor’s degree in Regulatory Affairs, Life Sciences, Engineering, or a related discipline. 

Preferred: Advanced degree or professional certification in Regulatory Affairs, Quality, or a related field. 
 

Experience and Skills 

Required: 

• 10–12 years of progressive experience in Quality Assurance and/or Regulatory Affairs within medical devices or other highly regulated industries. 
• Deep working knowledge of Japanese regulatory requirements and PMDA/MHLW processes. 
• Demonstrated experience leading regulatory and quality strategy and execution in Japan. 
• Proven ability to manage complex regulatory portfolios and risk in major, highly regulated markets. 
• Experience operating effectively in a global, matrixed organization with senior stakeholder engagement. 
• Strong leadership presence, sound judgment, and decision‑making capabilities. 
   

Preferred: 

• Experience supporting international QARA operating models. 
• Experience working in multinational or global medical device organizations. 
• Direct exposure to regulatory inspections, quality audits, and health authority negotiations in Japan. 
• Demonstrated success driving QARA transformation, process improvement, or operating model change. 
• Experience supporting diverse product portfolios across multiple therapeutic areas. 
• Regulatory Affairs or Quality certification (e.g., RAC or equivalent). 
   

Other 

Language: Japanese and English required. 

Travel: Moderate domestic and occasional international travel. 

Certifications: RAC or equivalent preferred but not required. 

For more information on how we support the whole health of our employees throughout their wellness, career and life journey, please visit www.careers.jnj.com.
 

 

 

Required Skills:

 

 

Preferred Skills:

Business Writing, Collaboration, Compliance Risk, Continuous Improvement, Developing Others, Fact-Based Decision Making, Inclusive Leadership, Industry Analysis, Innovation, Leadership, Legal Support, Operations Management, Public Policies, Regulatory Affairs Management, Regulatory Compliance, Regulatory Development, Regulatory Environment, Strategic Thinking