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, Warsaw, Indiana, United States of America, West Chester, Pennsylvania, United States of America
Job Description:DePuy Synthes is recruiting for a Sr. Source Regulatory Compliance Specialist, located in Palm Beach Gardens FL, Raynham MA, Warsaw, IN or West Chester PA.
Job Overview
The Sr. Source Regulatory Compliance Specialist is responsible for executing and supporting regulatory compliance activities related to sourcing, suppliers, and externally provided processes. This role ensures that suppliers, contract manufacturers, and sourced materials comply with applicable regulatory requirements, quality system standards, and internal policies. The position plays a key role in safeguarding product quality, supporting audit readiness, and enabling compliant supply continuity by partnering closely with Quality, Regulatory Affairs, Supply Chain, and Procurement teams.
Key Responsibilities
- Execute source regulatory compliance activities to ensure adherence to regulatory and quality system requirements.
- Support compliance oversight for suppliers, contract manufacturers, and externally provided processes.
- Partner with Supply Chain, Procurement, Quality, and Regulatory Affairs teams to support compliant supplier qualification and lifecycle management.
- Interpret regulatory requirements and support translation into sourcing and supplier compliance expectations.
- Support internal audits, external audits, and health authority inspections related to sourcing and supplier compliance.
- Monitor compliance risks, trends, and supplier performance metrics; support corrective and preventive actions.
- Ensure accurate maintenance of compliance documentation, records, and reports.
- Contribute to continuous improvement initiatives to strengthen sourcing compliance governance and effectiveness.
Qualifications
Education:
- Bachelor's degree in Regulatory Affairs, Quality, Engineering, Life Sciences, Supply Chain, or a related discipline (required).
- Advanced degree in a scientific or regulatory field (preferred).
Experience and Skills:
Required:
- Typically 4-6 years of experience in Regulatory Compliance, Quality, Supply Chain, or related roles within a regulated industry.
- Working knowledge of regulatory and quality requirements impacting sourcing and supplier operations.
- Experience supporting supplier audits, inspections, or compliance assessments.
- Ability to manage complex compliance topics and documentation with strong attention to detail.
Preferred:
- Experience in medical devices, healthcare, or other highly regulated industries.
- Familiarity with U.S. regulatory and supplier compliance expectations.
- Experience working in a global or matrixed organization.
- Exposure to regulatory inspections involving supplier or contract manufacturing oversight.
- Quality or Regulatory certifications (e.g., RAC, ASQ).
- Strong analytical, organizational, and problem-solving skills.
- Effective written and verbal communication skills.
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, Communication, Compliance Management, Compliance Policies, Compliance Risk, Controls Compliance, Critical Thinking, Problem Solving, Quality Auditing, Quality Control (QC), Quality Standards, Regulatory Environment, Standard Operating Procedure (SOP)
