Loc Sr Reg Compliance Specialist

Johnson & Johnson Johnson & Johnson · Pharma · Shanghai, China +1

This role is for a Senior Regulatory Compliance Specialist at Johnson & Johnson (DePuy Synthes) in Shanghai or Singapore. The primary responsibility is to lead and execute regulatory compliance activities for the local operating company, ensuring adherence to regulatory requirements, quality system standards, and internal policies for commercial and distribution activities. The role involves supporting internal and external audits, interpreting regulatory requirements, monitoring compliance risks, and contributing to continuous improvement initiatives.

What you'd actually do

  1. Execute and oversee regulatory compliance activities for the local operating company in alignment with global and regional compliance requirements.
  2. Support Schedule development of internal audits in the region, support response development, and track action to point of completion
  3. Ensure adherence to local regulatory requirements, internal policies, and quality system standards across commercial operations.
  4. Partner with Regulatory Affairs, Quality, Commercial, and Supply Chain teams to support compliant product distribution and lifecycle activities.
  5. Interpret regulatory requirements and translate them into practical compliance guidance for local stakeholders.

Skills

Required

  • Bachelor’s degree in Regulatory Affairs, Quality, Engineering, Life Sciences, or a related discipline
  • 4-6 years of experience in Regulatory Compliance, Quality, or related roles within a regulated industry
  • Strong working knowledge of regulatory and compliance requirements applicable to local commercial operations
  • Experience supporting audits, inspections, or compliance assessments
  • Ability to manage complex compliance topics with strong attention to detail
  • English required

Nice to have

  • Advanced degree in a scientific or regulatory field
  • Experience in medical devices, healthcare, or other highly regulated industries
  • Familiarity with APAC and Singapore regulatory and compliance expectations
  • Experience working in a global or matrixed organization
  • Exposure to regulatory inspections involving local operating companies
  • Quality or Regulatory certifications (e.g., RAC, ASQ)
  • additional APAC languages preferred
  • Quality or Regulatory certifications preferred but not required

What the JD emphasized

  • regulatory compliance
  • quality system standards
  • internal audits
  • health authority inspections