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Job Function:
Regulatory Affairs GroupJob Sub Function:
Regulatory AffairsJob Category:
People LeaderAll Job Posting Locations:
Mumbai, Maharashtra, IndiaJob 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 the International organization. This role is accountable for ensuring regulatory compliance, effective quality management system execution, and sustainable market access across diverse and highly regulated markets.
This position 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 country‑specific 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 cross‑functional 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.
Support and, as required, lead regulatory inspections, quality audits, and health authority interactions, ensuring timely and effective responses.
Lead, coach, and develop regional QARA talent, fostering strong compliance culture, 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: 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:
8–10 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 multi‑country regulatory and/or quality portfolios.
Proven ability to develop and execute regulatory and quality strategies aligned with business objectives.
Strong leadership, stakeholder management, and decision‑making capabilities.
Ability to operate effectively in a global, matrixed organization with cross‑regional collaboration.
Preferred:
Experience supporting International or emerging market regulatory and quality operating models.
Experience working in multinational medical device or 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: English required; additional Southeast Asian or Indian languages preferred.
Travel: Moderate international travel across Southeast Asia and India.
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 www.careers.jnj.com.
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.
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.
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Required Skills:
Preferred Skills:
Business Writing, Compliance Risk, Developing Others, Fact-Based Decision Making, Inclusive Leadership, Industry Analysis, Innovation, Leadership, Legal Support, Managing Managers, Operations Management, Policy Development, Product Licensing, Public Policies, Regulatory Affairs Management, Regulatory Compliance, Regulatory Development, Regulatory Environment, Strategic ThinkingJohnson & Johnson Mumbai, Maharashtra, IND Office
Arena Space, behind Majas Depot, Shyam Nagar, Jogeshwari East, Mumbai, Maharashtra, India, 400060
