Senior Tech Regulatory Compliance Lead

Johnson & Johnson MedTech; West Chester (Chester County); Sur place; USD 90 000 - 130 000; Plein temps

Résumé du poste

DePuy Synthes is seeking a Sr. Source Regulatory Compliance Specialist to lead technology regulatory compliance activities across multiple U.S. sites, including Palm Beach Gardens, FL; Raynham, MA; Warsaw, IN; and West Chester, PA.

The role partners with Quality, Regulatory Affairs, Engineering, and IT to ensure alignment with regulatory standards and quality systems, while supporting audits, inspections, and CAPA programs to strengthen governance and risk management.

Qualifications

• 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.

Responsabilités

• 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.

Connaissances

Regulatory compliance experience

Quality systems knowledge

Audits & inspections experience

Cross-functional collaboration

Formation

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

Advanced degree in a scientific, regulatory, or technical field

Description du poste

DePuy Synthes is seeking a Sr. Source Regulatory Compliance Specialist to lead technology regulatory compliance activities across multiple U.S. sites, including Palm Beach Gardens, FL; Raynham, MA; Warsaw, IN; and West Chester, PA.

The role partners with Quality, Regulatory Affairs, Engineering, and IT to ensure alignment with regulatory standards and quality systems, while supporting audits, inspections, and CAPA programs to strengthen governance and risk management.