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Sr. Source Regulatory Compliance Specialist

Johnson & Johnson

Senior regulatory compliance specialist role focused on leading technology and quality system compliance activities across medical device operations. Responsible for audit management, regulatory risk oversight, and cross-functional collaboration to ensure adherence to technical and quality standards in a regulated healthcare environment.

Responsibilities

  • Lead technology regulatory compliance activities ensuring adherence to regulatory and quality system requirements
  • Provide compliance oversight for technology processes, systems, and documentation supporting regulated activities
  • Conduct internal and external audits and support health authority inspection readiness
  • Partner with Quality, Regulatory Affairs, Engineering, and IT teams on compliant system implementation
  • Monitor compliance risks and trends; drive corrective and preventive actions

Requirements

  • Bachelor's degree in Regulatory Affairs, Quality, Engineering, Life Sciences, or related discipline
  • 6-8 years progressive experience in regulatory compliance, quality systems, or engineering in regulated industries
  • Strong knowledge of regulatory and technical requirements impacting quality systems
  • Experience supporting audits, inspections, and compliance assessments
  • Ability to manage complex technical compliance topics across cross-functional teams
  • Medical device or healthcare industry experience preferred
  • Quality or Regulatory certifications (RAC, ASQ) preferred
Vacancy posted 6 days ago
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