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About the Role

The Director, QARA Japan provides senior leadership for quality assurance and regulatory affairs for DePuy Synthes in Japan, a complex and highly regulated market. This role is accountable for regulatory compliance, quality management system execution, and sustainable market access across the full product lifecycle, safeguarding patient safety while enabling innovation and business growth.

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.
• Partner with cross‑functional stakeholders 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.
• Ensure proactive engagement and shaping of regional policy initiatives that are critical to business strategy, continuity, and growth.

Requirements

• Bachelor’s degree in Regulatory Affairs, Life Sciences, Engineering, or a related discipline.
• 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.
• Japanese and English required.
• Moderate domestic and occasional international travel.

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
• Advanced degree or professional certification in Regulatory Affairs, Quality, or a related field.
• 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).

Location

• Chiyoda, Tokyo, Japan

Work Type

• Hybrid

Experience Level

• 10-12 years of progressive experience in Quality Assurance and/or Regulatory Affairs within medical devices or other highly regulated industries.

Education Level

• Bachelor’s degree in Regulatory Affairs, Life Sciences, Engineering, or a related discipline.
• Advanced degree or professional certification in Regulatory Affairs, Quality, or a related field.

About the Company

• At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity.
• 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 plans. In 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.

Equal Opportunity

• 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 https://www.jnj.com/contact-us/careers, internal employees contact AskGS to be directed to your accommodation resource.