Director, QARA Japan

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. Learn more at jnj.com . As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit. 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.

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.

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