West Chester, Pennsylvania, United States of America, United States of America
Hybrid
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Job Function:
QualityJob Sub Function:
Quality & Compliance AuditJob Category:
ProfessionalAll Job Posting Locations:
Palm Beach Gardens, Florida, United States of America, Raynham, Massachusetts, United States of America, West Chester, Pennsylvania, United States of AmericaJob Description:
DePuy Synthes is recruiting for a Sr. Manager, Technical Regulatory Compliance, located in West Chester PA or Palm Beach Gardens FL or Raynham MA.
Job Overview
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.
Key Responsibilities
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.
Qualifications
Education:
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).
Experience and Skills:
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 manufacturing processes.
Demonstrated experience leading audits, inspections, and regulatory assessments.
Proven ability to manage complex technical compliance topics across cross‑functional stakeholder groups.
Preferred:
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.
Other:
Language: English required.
Travel: Limited; occasional domestic travel.
Certifications: Quality or Regulatory certifications preferred but not required.
For more information on how we support the whole health of our employees throughout their wellness, career and life journey, please visit www.careers.jnj.com.
Johnson & Johnson announced plans to separate our Orthopaedics business to establish a standalone orthopaedics company, operating as DePuy Synthes. The process of the planned separation is anticipated to be completed within 18 to 24 months, subject to legal requirements, including consultation with works councils and other employee representative bodies, as may be required, regulatory approvals and other customary conditions and approvals. Should you accept this position, it is anticipated that, following conclusion of the transaction, you would be an employee of DePuy Synthes and your employment would be governed by DePuy Synthes employment processes, programs, policies, and benefit plans. In that case, details of any planned changes would be provided to you by DePuy Synthes at an appropriate time and subject to any necessary consultation processes.
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 by 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.
Johnson & Johnson is committed to providing an interview process that is inclusive of our applicants’ needs. If you are an individual with a disability and would like to request an accommodation, external applicants please contact us via https://www.jnj.com/contact-us/careers, internal employees contact AskGS to be directed to your accommodation resource.
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Required Skills:
Preferred Skills:
Agile Internal Audit, Analytical Reasoning, Audit and Compliance Trends, Compliance Frameworks, Compliance Management, Compliance Policies, Compliance Risk, Critical Thinking, Organizing, Quality Auditing, Quality Control (QC), Quality Standards, Regulatory Compliance, Risk Management, Technical Credibility, Third-Party AuditingWant to know if this job is worth applying to?