Senior Source Regulatory Compliance Specialist

Johnson & Johnson

. Lead and manage technology regulatory compliance activities .

Posted 10/13/2026full-timeUnited StatesSeniorWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in regulatory compliance and quality systems within highly regulated industries, with a strong focus on managing compliance activities, conducting audits, and driving continuous improvement initiatives. Proficient in interpreting regulatory standards and collaborating with cross-functional teams to ensure adherence to compliance requirements.

Highest-signal resume keywords

Regulatory Compliance ManagementQuality Systems OversightAudit and Inspection SupportRisk Management and AnalysisRegulatory Affairs Certification

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Regulatory ComplianceQuality SystemsTechnical ComplianceAudit SupportRegulatory Standards InterpretationCompliance Risk MonitoringCorrective and Preventive ActionsContinuous Improvement InitiativesDocumentation OversightCompliance Assessment

Soft Skills

Analytical SkillsProblem-Solving SkillsEffective Communication

Certifications & Qualifications

Regulatory Affairs Certification (RAC)American Society for Quality (ASQ)

Industry Keywords

Medical DevicesHealthcareRegulated IndustryEMEA Regulatory FrameworksGlobal Compliance

About the role

Key responsibilities & impact

Lead and manage technology regulatory compliance activities
Provide compliance oversight for technology processes, systems, and documentation supporting regulated activities
Interpret regulatory and technology standards and translate them into actionable compliance requirements
Partner with Quality, Regulatory Affairs, Engineering, and IT teams on compliant systems and process implementation
Conduct internal and external audits and support health authority inspections
Monitor compliance risks, trends, and performance metrics
Drive corrective and preventive actions
Ensure consistent application of global and regional compliance policies, procedures, and controls
Drive continuous improvement initiatives to strengthen technical compliance, governance, and effectiveness

Requirements

What you’ll need

Bachelor’s degree in Regulatory Affairs, Quality, Engineering, Life Sciences, Information Systems, or related discipline (required)
Typically 6-8 years of progressive experience in Regulatory Compliance, Quality Systems, Engineering, or related roles within a regulated industry
Strong working knowledge of regulatory and technical requirements impacting quality systems and processes
Experience supporting audits, inspections, and compliance assessments
Ability to manage complex technical compliance topics across cross-functional stakeholder groups
Experience in medical devices, healthcare, or other highly regulated industries preferred
Familiarity with EMEA regulatory and technical compliance frameworks preferred
Experience working in a global or matrixed organization preferred
Exposure to regulatory inspections involving technical or system compliance preferred
Quality or Regulatory certifications (e.g., RAC, ASQ) preferred but not required
English required; additional European languages preferred
Moderate regional travel across EMEA
Strong analytical, risk-management, and problem-solving skills preferred
Effective written and verbal communication skills preferred

Benefits

Comp & perks

Inclusive work environment
Employee wellness, career, and life support
Reasonable accommodation support for applicants with disabilities