Manager, RA SE Asia Dist. & Ops

DePuy Synthes is recruiting for a Manager, RA SE Asia Dist. & Ops, located in Singapore, Central Singapore. 

The Manager, RA SE Asia Distribution & Operations, is responsible for leading regulatory affairs activities across Southeast Asia distributor and operations markets. This role ensures compliance with local regulatory requirements, supports product registrations and lifecycle activities, and enables timely market access. The position plays a critical role in partnering with distributors, regional teams, and global stakeholders to navigate regulatory complexity and support sustainable business growth across diverse markets. 

Key Responsibilities 

• Lead and manage regulatory affairs activities supporting distributor‑led and operational markets across Southeast Asia. 

• Ensure compliance with local regulatory requirements, internal policies, and quality system standards. 

• Act as the primary regulatory contact for Southeast Asia distributor and operations markets. 

• Coordinate regulatory submissions, renewals, variations, and responses to health authority inquiries. 

• Partner with distributors and cross‑functional teams including Quality, Supply Chain, Commercial, and Global Regulatory Affairs. 

• Monitor regulatory changes across Southeast Asia and assess potential impact on products and operations. 

• Support regulatory inspections, audits, and assessments as required. 

• Contribute to continuous improvement initiatives to enhance regulatory efficiency, compliance, and distributor governance. 

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

Qualifications 

Education: 

• Bachelor’s degree in Regulatory Affairs, Life Sciences, Engineering, or a related discipline (required). 

• Advanced degree or professional certification in Regulatory Affairs (preferred). 

Experience and Skills: 

Required: 

• Typically 6-8 years of progressive experience in Regulatory Affairs within the medical device, healthcare, or regulated industry. 

• Strong knowledge of regulatory requirements across Southeast Asia markets. 

• Experience supporting distributor‑based business models and operational markets. 

• Proven ability to manage product registrations and lifecycle activities across multiple countries. 

• Strong stakeholder management and communication skills, including distributor engagement. 

• Ability to manage multiple priorities in a complex, fast‑paced environment. 

Preferred: 

• Experience supporting international or emerging markets. 

• Familiarity with ASEAN regulatory frameworks and harmonization initiatives. 

• Experience working in a multinational or matrixed organization. 

• Exposure to regulatory audits, inspections, or health authority interactions. 

• Demonstrated experience driving regulatory process improvement initiatives. 

Other: 

• Language: English required; additional Southeast Asian languages preferred. 

• Travel: Moderate regional travel across Southeast Asia distributor and operations markets. 

• Certifications: RAC or equivalent preferred but not required. 

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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