The Manager, Source RegulatoryCompliance,is responsible forleading regulatory compliance activities related to sourcing, suppliers, and externally provided processes. This role ensures that suppliers, contract manufacturers, and sourced materialscomply withapplicable 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.

Key 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 sourcingcompliance,governance,and effectiveness.

Qualifications

Education:

• Bachelor’s degree in Regulatory Affairs, Quality, Engineering, Life Sciences, Supply Chain, orrelateddiscipline (required).

• Advanced degree in a scientific, regulatory, or business field (preferred).

Experience and Skills:

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 requirementsimpactingsourcing 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.

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).

Other:

• Language: Englishrequired

• Travel:Moderatedomestic travel.

• Certifications: Quality or Regulatory certifications preferred but notrequired