Loc/dc Regulatory Compliance Specialist

Johnson & Johnson Johnson & Johnson · Pharma · Mooresville, IN +1

This role supports regulatory compliance activities for a local operating company and distribution center, ensuring adherence to regulatory requirements, quality system standards, and internal policies. Responsibilities include supporting internal and external audits, monitoring compliance risks, and maintaining documentation. The role requires experience in a regulated industry and strong collaboration skills.

What you'd actually do

  1. Support regulatory compliance activities for the local operating company and distribution center in alignment with global and regional 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 applicable regulatory requirements, internal policies, and quality system standards across LOC/DC operations.
  4. Partner with Quality, Regulatory Affairs, Supply Chain, and Operations teams to support compliant product storage, handling, and distribution.
  5. Interpret regulatory and compliance requirements and translate them into local procedures and operational controls.

Skills

Required

  • Regulatory compliance
  • Quality systems
  • Audit support
  • Documentation management
  • Cross-functional collaboration

Nice to have

  • Medical device experience
  • Healthcare industry experience
  • US regulatory and distribution compliance
  • Global/matrixed organization experience
  • Distribution center inspection experience
  • Quality or Regulatory certifications (e.g., RAC, ASQ)

What the JD emphasized

  • Bachelor’s degree in Regulatory Affairs, Quality, Engineering, Life Sciences, Supply Chain, or a related discipline (required)
  • Typically 4-6 years of experience in Regulatory Compliance, Quality, or related roles within a regulated industry
  • Working knowledge of regulatory and quality requirements impacting commercial and distribution operations
  • Experience supporting audits, inspections, or compliance assessments
  • Strong attention to detail with the ability to manage compliance documentation accurately
  • Effective communication and cross‑functional collaboration skills