Senior Source Regulatory Compliance Specialist

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 has a direct impact on product quality, audit readiness, and supply continuity by partnering closely with Quality, Regulatory Affairs, Supply Chain, and Procurement teams across the region. 

Key Responsibilities 

• Execute source regulatory compliance activities including supplier audit execution, investigation approval, and objective evidence review, to ensure adherence to regulatory and quality system requirements 

• Support compliance oversight for suppliers, contract manufacturers, and externally provided services. 

• 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 supplier 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 leading supplier audits, inspections, or compliance assessments. 

• Ability to manage complex compliance topics and documentation with strong attention to detail. 

• Strong analytical, organizational, and problem‑solving skills. 

• Effective written and verbal communication skills. 

Preferred: 

• Experience in medical devices, healthcare, or other highly regulated industries. 

• Familiarity with global 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 required, additional European language preferred 

• Travel: moderate regional; limited international travel. 

• Certifications: Quality or Regulatory certifications preferred but not required. 

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