Senior Tech Regulatory Compliance Lead

6149-DePuy Synthes Products Inc. Legal Entity; North Palm Beach (FL); Vor Ort; USD 110.000 - 140.000; Vollzeit

Zusammenfassung

Johnson & Johnson is seeking a Sr. Source Regulatory Compliance Specialist to lead technology regulatory compliance initiatives across multiple sites in the U.S.

This role collaborates with Quality, Regulatory Affairs, Engineering, and IT to ensure compliant systems and documentation. The position requires 6–8 years in regulatory compliance or quality systems, experience with audits/inspections, and strong analytical skills to identify and mitigate compliance risks while enabling effective

Qualifikationen

• 6–8 years of progressive experience in Regulatory Compliance or Quality Systems.
• Strong working knowledge of regulatory requirements impacting quality systems.
• Experience supporting audits, inspections, and compliance assessments.
• Ability to manage complex technical compliance topics across stakeholders.

Aufgaben

• Lead and manage technology regulatory compliance activities, ensuring adherence to regulatory and quality system requirements.
• 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 to support compliant systems and process implementation.
• Conduct internal audits, external audits, and support health authority inspections in support of product and non-product technology regulatory compliance.
• 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.

Kenntnisse

Regulatory compliance

Quality systems

Audits & inspections

Cross-functional collaboration

Ausbildung

Bachelor’s degree in Regulatory Affairs, Quality, Engineering, Life Sciences, Information Systems, or related discipline

Advanced degree in a scientific, regulatory, or technical field

Jobbeschreibung

Johnson & Johnson is seeking a Sr. Source Regulatory Compliance Specialist to lead technology regulatory compliance initiatives across multiple sites in the U.S.

This role collaborates with Quality, Regulatory Affairs, Engineering, and IT to ensure compliant systems and documentation. The position requires 6–8 years in regulatory compliance or quality systems, experience with audits/inspections, and strong analytical skills to identify and mitigate compliance risks while enabling effective