Director, QARA Japan
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Job Summary
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Job Function:
Regulatory Affairs GroupJob Sub Function:
Regulatory AffairsJob Category:
People LeaderAll Job Posting Locations:
Chiyoda Tokyo JapanJob 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 companys 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 crossfunctional 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: Bachelors 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:
- 1012 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 decisionmaking 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 .
Johnson & Johnson announced plans to separate our Orthopaedics business to establish a standalone orthopaedics company operating as DePuy Synthes. The process of the planned separation is anticipated to be completed within 18 to 24 months subject to legal requirements including consultation with works councils and other employee representative bodies as may be required regulatory approvals and other customary conditions and approvals. Should you accept this position it is anticipated that following conclusion of the transaction you would be an employee of DePuy Synthes and your employment would be governed by DePuy Synthes employment processes programs policies and benefit that case details of any planned changes would be provided to you by DePuy Synthes at an appropriate time and subject to any necessary consultation processes.
Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race color religion sex sexual orientation gender identity age national origin disability protected veteran status or other characteristics protected by federal state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act.
Johnson & Johnson is committed to providing an interview process that is inclusive of our applicants needs. If you are an individual with a disability and would like to request an accommodation external applicants please contact us via internal employees contact AskGS to be directed to your accommodation resource.
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Director
About Company
About Johnson & Johnson A t Johnson & Johnson, we believe good health is the foundation of vibrant lives, thriving communities and forward progress. That’s why for more than 130 years, we have aimed to keep people well at every age and every stage of life. Today, as the world’s larges ... View more
