Job Function: Quality
Job Sub Function: Quality & Compliance Audit
Job Category:Professional
All Job Posting Locations:Palm Beach Gardens, Florida, United States of America, Raynham, Massachusetts, United States of America, West Chester, Pennsylvania, United States of America
Job Description:DePuy Synthes is recruiting for a Manager, Technical Regulatory Compliance, located in Raynham MA or Palm Beach Gardens FL or West Chester PA.
Job Overview
The Manager, Technical Regulatory Compliance is responsible for leading compliance activities related to technical, system, and process regulatory requirements. This role ensures that technical operations, systems, and documentation comply with applicable regulations, 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 technical initiatives by partnering closely with Quality, Regulatory Affairs, Engineering, Manufacturing, and IT teams.
Key Responsibilities
- Lead and manage technical regulatory compliance activities in alignment with global and regional compliance strategies.
- Provide compliance oversight for technical processes, systems, and documentation supporting regulated activities.
- Interpret regulatory and technical standards and translate them into actionable compliance requirements.
- Partner with Quality, Regulatory Affairs, Engineering, Manufacturing, and IT teams to support compliant system and process implementation.
- Support internal audits, external audits, and health authority inspections related to technical compliance.
- 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 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.
- Experience supporting audits, inspections, and regulatory assessments.
- Ability to manage complex technical compliance topics across cross-functional stakeholder groups.
- Strong analytical, risk-management, and problem-solving skills.
- Effective written and verbal communication skills.
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 regulatory inspections involving technical or system compliance.
- Quality or Regulatory certifications (e.g., RAC, ASQ).
Other:
- Language: English required.
- Travel: Limited; occasional domestic travel.
- Certifications: Quality or Regulatory certifications preferred but not required.
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.
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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, Controls Compliance, Critical Thinking, Developing Others, Inclusive Leadership, Leadership, Problem Solving, Quality Auditing, Quality Control (QC), Quality Standards, Regulatory Compliance, Regulatory Environment, Risk Management, Supervision, Third-Party Auditing
