Director, Quality Assurance, Regulatory Affairs, Distribution and Operations, APAC

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DePuy Synthes is recruiting for a Director Quality Assurance Regulatory Affairs Distribution and Operations APAC in North Ryde Australia or Shanghai China Maharashtra India or Seoul Korea.

• Join our change journey at J&Jhelp shape whats next

• Step into a high-impact career opportunity with real visibility

THE OPPORTUNITY

TheDirector Quality Assurance Regulatory Affairs Distribution and Operationsprovides enterpriselevel leadership for quality assurance and regulatory affairs across the AsiaPacific region. With accountability for local market regulatory compliance quality management system execution and sustainable market access this role shapes and executes the regional QARA strategy in alignment with global priorities.

Thisposition is a key member of the international QARA leadership team and partners closely with Global QARA Commercial Operations and Supply Chain has a significant impact on patient safety compliance outcomes and thelongtermsuccess of the APAC portfolio across diverse and highly regulated markets.

RESPONSIBILITIES

• Lead and execute the APAC Quality Assurance and Regulatory Affairs strategy in alignment with global QARA objectives and international business priorities.

• Provide executive oversight forcountryspecific regulatory submissions approvals renewals variations and lifecycle management activities across APAC markets.

• Ensure ongoing compliance with regional and local regulatory requirements quality management system standards and internal policies and procedures.

• Serve as the senior escalation point for APAC QARA issues including regulatory risk quality system gaps and health authority interactions.

• Partner with Commercial Operations Supply Chain Legal and Global QARA leaders to support product launches supply continuity and portfolio optimization.

• Monitor interpret and communicate emerging regulatory and quality trends across APAC proactively assessing business compliance and patient safety impact.

• Oversee and support regulatory inspections quality audits and health authority engagements ensuringtimely consistent and effective responses.

• Lead develop and mentor APAC QARA leaders and teams building strong succession pipelines capability and performance across the region.

• Drive continuous improvement simplification and harmonization of quality and regulatory processes across APAC local markets.

• Ensuring proactive engagement and shaping of regional policy initiatives that are critical to business strategy continuity and growth.

• Define distributor markets and design processes and systems that enable an efficient Distribution Management structure.

ABOUT YOU

Required:

• Bachelors degree in Regulatory Affairs Life Sciences Engineering ora relateddiscipline.

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

• Demonstrated experience leading multicountry or regional QARA portfolios preferably across APAC markets.

• Strong working knowledge of international and local regulatory frameworks and quality management system requirements.

• Proven ability to develop and execute quality and regulatory strategies aligned with businessobjectives.

• Experienceoperatingeffectively in a global matrixed organization with senior executive stakeholder engagement.

• Strong leadership presence sound judgment and decisionmaking capabilities in complex regulatory and quality environments.

Desirable:

• Advanced degree or professional certification in Regulatory Affairs Quality ora relatedfield.

• Experience supportingInternationalor emerging market regulatory and quality operating models.

• Direct experience leading regulatory inspections quality audits and negotiations with APAC health authorities.

• Demonstrated success driving quality or regulatory transformation simplification or operating model change.

• Experience within orthopedics medical devices or healthcare manufacturing environments.

• Track recordof developing highperforming regional leadership teams.

Other:

• Language: Englishrequired;additionalAPAC languages preferred.

• Travel: Moderate international travel across APAC markets.

• Certifications: RAC or equivalent certification preferred.

COMPANY CULTURE

• Competitive remuneration package.

• Continuous training and support.

• Award-winning leadership development programs.

• Inclusive flexible and accessible working arrangements.

• Equal opportunity employer supporting diversity and inclusion.

WHY CHOOSE US:

• Competitive remuneration package and continuous training.

• Supportive environment with award-winning leadership development programs.

• Inclusive flexible and accessible working arrangements for all.

Johnson & Johnson has announced plans to separate our Orthopaedics business to establish a standalone orthopaedics company. The planned separation is anticipated to be completed within 18 to 24 months subject to satisfaction of legal and regulatory requirements 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 the standalone orthopaedics company and your employment would be governed by the standalone orthopaedics companys employment processes programs policies and benefit that case details of any planned changes would be provided to you by the standalone orthopaedics company at an appropriate time and subject to any necessary consultation processes.

Johnson & Johnsonisan 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 federalstateor local law. We actively seek qualified candidates who areprotectedveterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act.

Johnson & Johnsoniscommitted to providing an interview process that is inclusive of our applicants needs. If you are an individual with a disability and would like to requestan accommodation external applicants please contact us via internal employees contactAskGSto be directed to your accommodation resource.

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