Sr. Source Reg Compliance Specialist

Job Overview

The Sr. Source Regulatory Compliance Specialistis responsible forexecuting and supporting 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 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 providedservices.

• 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 performancemetrics;support corrective and preventive actions.

• Ensureaccuratemaintenance of compliance documentation records and reports.

• Contribute to continuous improvement initiatives to strengthen suppliercompliancegovernance and effectiveness.

Qualifications

Education:

• Bachelors degree in Regulatory Affairs Quality Engineering Life Sciences Supply Chain ora relateddiscipline (required).

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

Experience and Skills:

Required:

• Typically4-6years of experience in Regulatory Compliance Quality Supply Chain or related roles within a regulated industry.

• Working knowledge of regulatory and quality requirementsimpactingsourcing and supplier operations.

• Experienceleadingsupplier audits inspections or compliance assessments.

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

• Strong analytical organizational and problemsolving skills.

• Effective written and verbal communication skills.

Preferred:

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

• Familiarity withglobalregulatory 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: EnglishadditionalEuropean language preferred

• Travel:moderate regional;limited internationaltravel.

• Certifications: Quality or Regulatory certifications preferred but not.

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