Manager, Source Reg Compliance

The Manager Source RegulatoryComplianceis 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 sourcingcompliancegovernanceand effectiveness.

Qualifications

Education:

• Bachelors 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:

• Typically6-8 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 crossfunctional stakeholder groups.

• Strong analytical riskmanagement and problemsolving 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: English.

• Travel:Moderatedomestic travel.

• Certifications: Quality or Regulatory certifications preferred but not.