Sr. Source Regulatory Compliance Specialist

Johnson & Johnson Innovative Medicine • Warsaw, IN

3d • Hybrid

About The Position

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.

Requirements

• Bachelor’s degree in Regulatory Affairs, Quality, Engineering, Life Sciences, Supply Chain, or a related discipline (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.
• English required.

Nice To Haves

• Advanced degree in a scientific or regulatory 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).
• Strong analytical, organizational, and problem‑solving skills.
• Effective written and verbal communication skills.

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.

Benefits

• Inclusive work environment where each person is considered as an individual.
• Respect for the diversity and dignity of employees and recognition of their merit.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior