Job Posting Title Associate Director, QARA SE Asia & India

At Johnson & Johnsonwe believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented treated and curedwhere treatments are smarter and less invasive andsolutions are 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 more at .

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:

Job Sub Function:

Job Category:

All Job Posting Locations:

Job Description:

DePuy Synthes is recruiting for an Associate Director Quality Assurance & Regulatory Affairs (QARA) Southeast Asia & India located in Singapore or Malaysia or India

The Associate Director Quality Assurance & Regulatory Affairs (QARA) Southeast Asia & India provides regional leadership for quality assurance and regulatory affairs across Southeast Asia and India as part of role is accountable for ensuring regulatory compliance effective quality management system execution and sustainable market access across diverse and highly regulated markets.

Thisposition partners closely with Commercial Operations Supply Chain Quality and Global QARA teams to manage regulatory and quality risk shape regional QARA strategy and enable compliant business growth while safeguarding patient safety.

Key Responsibilities

• Lead and oversee the Quality Assurance and Regulatory Affairs strategy and execution across Southeast Asia and India in alignment with global QARA and international priorities.

• Ensure compliance with countryspecific regulatory requirements quality management system standards and internal policies and procedures.

• Provide strategic regulatory and quality guidance to support product registrations renewals variations and lifecycle management across the region.

• Serve as the senior QARA escalation point for Southeast Asia & India Local Market Support within the ROW organization.

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

• Monitor interpret and communicate emerging regulatory and quality trends across Southeast Asia and India proactively assessing business and compliance impact.

• Supportandasrequired lead regulatory inspections quality audits and health authority interactions ensuringtimelyand effective responses.

• Lead coach and develop regional QARA talent fostering strongcomplianceculture accountability and performance.

• Drive continuous improvement simplification and harmonization of QARA processes across Southeast Asia and India markets.

• 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 ora relateddiscipline.

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

Experience and Skills

Required:

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

• Strong working knowledge of regulatory and quality requirements across Southeast Asia and India.

• Demonstrated experience leading multicountry regulatory and/or quality portfolios.

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

• Strong leadership stakeholder management and decisionmaking capabilities.

• Ability tooperateeffectively in a global matrixed organization with crossregional collaboration.

Preferred:

• Experience supportingInternationalor emerging market regulatory and quality operating models.

• Experience working in multinational medicaldeviceor healthcare organizations.

• Exposure to regulatory inspections quality audits and health authority negotiations.

• Demonstrated success driving QARA transformation process improvement or operational simplification initiatives.

• Regulatory Affairs Certification (RAC) or equivalent.

Other

• Language: Englishrequired;additionalSoutheast Asian or Indian languages preferred.

• Travel: Moderate international travel across Southeast Asia and India.

• Certifications: RAC or equivalent preferred but notrequired.

For more information on how we support the whole health of our employees throughout their wellnesscareerand 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.

#LI-Hybrid

#DePuySynthesCareers

Required Skills:

Preferred Skills: