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 5 hours ago
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