Manager, Source Reg Compliance (APAC)

Job Overview 

The Manager, Source Regulatory Compliance (APAC) is responsible for leading regulatory compliance activities related to sourcing, suppliers, and externally provided processes across the Asia‑Pacific region. This role ensures that suppliers, contract manufacturers, and sourced materials comply with applicable regulatory requirements, quality system standards, and internal policies. The position plays a critical role in safeguarding product quality, supporting audit readiness, and enabling compliant supply continuity across diverse APAC markets by partnering closely with Quality, Regulatory Affairs, Supply Chain, and Procurement teams. 

Key Responsibilities 

• Lead and manage source regulatory compliance activities across APAC, ensuring adherence to regulatory and quality system requirements. 

• Provide regulatory compliance oversight for suppliers, contract manufacturers, and externally provided processes. 

• Partner with Supply Chain, Procurement, Quality, and Regulatory Affairs teams to support compliant supplier qualification, monitoring, and lifecycle management. 

• Interpret regional and country‑specific regulatory requirements and translate them into sourcing and supplier compliance expectations. 

• Support internal audits, external audits, and health authority inspections related to sourcing and supplier compliance. 

• Monitor compliance risks, trends, and supplier performance metrics; drive corrective and preventive actions. 

• Ensure consistent application of global and regional compliance policies, procedures, and controls across APAC. 

• Drive continuous improvement initiatives to strengthen sourcing compliance governance and effectiveness. 

Qualifications 

Education: 

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

• Advanced degree in a scientific, regulatory, or business field (preferred). 

Experience and Skills: 

Required: 

• Typically 6-8 years of progressive experience in Regulatory Compliance, Quality, Supply Chain, or related roles within a regulated industry. 

• Strong working knowledge of regulatory and quality requirements impacting sourcing and supplier operations. 

• Experience supporting supplier audits, inspections, and compliance assessments. 

• Ability to manage complex compliance topics across multiple countries and stakeholder groups. 

• Strong analytical, risk‑management, and problem‑solving skills. 

• Effective written and verbal communication skills. 

Preferred: 

• Experience in medical devices, healthcare, or other highly regulated industries. 

• Familiarity with APAC regulatory authorities and supplier compliance frameworks. 

• Experience working in a global or matrixed organization. 

• Exposure to regulatory inspections involving supplier or contract manufacturing oversight. 

• Quality or Regulatory certifications (e.g., RAC, ASQ). 

Other: 

• Language: English required; Mandarin and/or additional APAC languages preferred. 

• Travel: Moderate regional travel across APAC. 

• Certifications: Quality or Regulatory certifications preferred but not required. 

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