Sr. Manager, Technical Regulatory Compliance

DePuy Synthes is recruiting for a Sr. Manager, Technical Regulatory Compliance located in West Chester, PA or Palm Beach Gardens, FL or Raynham, MA.

Quality

Quality & Compliance Audit

Professional

• Palm Beach Gardens, Florida, United States of America
• Raynham, Massachusetts, United States of America
• West Chester, Pennsylvania, United States of America

The Sr. Manager, Technical Regulatory Compliance provides senior leadership for regulatory compliance related to technical systems, processes, and documentation. This role ensures that technical and operational activities comply with applicable regulatory requirements, quality system standards, and internal policies. The position plays a critical role in managing compliance risk, supporting audit and inspection readiness, and enabling compliant execution of complex technical initiatives by partnering closely with Quality, Regulatory Affairs, Engineering, Manufacturing, and IT teams.

• Lead and oversee technical regulatory compliance activities in alignment with global and regional compliance strategies.
• Provide compliance oversight for technical processes, computerized systems, and documentation supporting regulated activities.
• Interpret regulatory and technical standards and translate them into actionable compliance requirements and controls.
• Partner with Quality, Regulatory Affairs, Engineering, Manufacturing, and IT teams to ensure compliant system implementation and change management.
• Lead audit and inspection readiness related to technical compliance, including internal audits and health authority inspections.
• Monitor compliance risks, trends, and performance metrics and drive corrective and preventive actions.
• Ensure consistent application of global and site‑specific compliance policies, procedures, and controls.
• Drive continuous improvement initiatives to strengthen technical compliance governance, efficiency, and effectiveness.

• Bachelor’s degree in Regulatory Affairs, Quality, Engineering, Life Sciences, Information Systems, or a related discipline (required).
• Advanced degree in a scientific, regulatory, or technical field (preferred).

• 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 manufacturing processes.
• Demonstrated experience leading audits, inspections, and regulatory assessments.
• Proven ability to manage complex technical compliance topics across cross‑functional stakeholder groups.

• Experience in medical devices, healthcare, or other highly regulated industries.
• Familiarity with U.S. regulatory and technical compliance frameworks.
• Experience working in a global or matrixed organization.
• Exposure to computerized system validation (CSV) or data integrity programs.
• Quality or Regulatory certifications (e.g., RAC, ASQ).
• Strong analytical, risk‑management, and problem‑solving skills.
• Effective written and verbal communication skills with senior stakeholders.

• Language:
  English required.
• Travel:
  Limited; occasional domestic travel.
• Certifications:
  
  Quality or Regulatory certifications preferred but not required.

Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status or other characteristics protected under federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act.