Manager, Source Reg Compliance
About The Position
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. DePuy Synthes is recruiting for a Source Regulatory Compliance Manager located in Raynham, Massachusetts, United States The Manager, Source Regulatory Compliance, is responsible for leading 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 critical 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.
Requirements
- Bachelor’s degree in Regulatory Affairs, Quality, Engineering, Life Sciences, Supply Chain, or related discipline (required).
- Typically, 6-8 years of progressive experience in Regulatory Compliance, Quality, Supply Chain, or related roles within a regulated industry.
- Strong working knowledge of regulatory and quality requirements impacting sourcing and supplier operations.
- Experience supporting supplier audits, inspections, and compliance assessments.
- Ability to manage complex compliance topics across cross‑functional stakeholder groups.
- Strong analytical, risk‑management, and problem‑solving skills.
- Effective written and verbal communication skills.
- English required.
Nice To Haves
- Advanced degree in a scientific, regulatory, or business field (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).
- Quality or Regulatory certifications preferred but not required.
Responsibilities
- Lead and manage source regulatory compliance activities, ensuring adherence to regulatory and quality system requirements.
- Provide compliance oversight for suppliers, contract manufacturers, and externally provided processes.
- Partner with Supply Chain, Procurement, Quality, and Regulatory Affairs to support compliant supplier qualification and lifecycle management.
- Interpret regulatory requirements and translate them into sourcing and supplier compliance expectations.
- Support internal audits, external audits, and health authority inspections related to supplier and sourcing compliance.
- Monitor compliance risks, trends, and supplier 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 sourcing compliance, governance, and effectiveness.
Benefits
- Vacation –120 hours per calendar year
- Sick time - 40 hours per calendar year; for employees who reside in the State of Colorado –48 hours per calendar year; for employees who reside in the State of Washington –56 hours per calendar year
- Holiday pay, including Floating Holidays –13 days per calendar year
- Work, Personal and Family Time - up to 40 hours per calendar year
- Parental Leave – 480 hours within one year of the birth/adoption/foster care of a child
- Bereavement Leave – 240 hours for an immediate family member: 40 hours for an extended family member per calendar year
- Caregiver Leave – 80 hours in a 52-week rolling period
- Volunteer Leave – 32 hours per calendar year
- Military Spouse Time-Off – 80 hours per calendar year
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What This Job Offers
Job Type
Full-time
Career Level
Manager
