Senior Regulatory Audit & Compliance Specialist
This senior position sits within a global healthcare leader’s high-growth Diagnostics business unit. Reporting to the Audit & Inspection Readiness Manager, the successful candidate will lead the supplier audit lifecycle and maintain a state of continuous inspection readiness across multi-site manufacturing networks.

Key Responsibilities

• Audit Lifecycle Leadership: Independently plan, execute, and report on global supplier, internal, and external quality system audits.
• Regulatory Compliance: Ensure all Quality Management System (QMS) and supplier activities strictly comply with global corporate standards and external regulations (MDSAP, MDR/IVDR, and cGMP).
• Data-Driven Oversight: Maintain the supplier audit schedule and track metrics; analyze and trend audit findings to proactively identify and mitigate systemic supply chain risks.
• Inspection Readiness & Hosting: Prepare sites for external regulatory inspections and corporate audits. Lead front-room/back-room logistics, manage document reviews, and coach subject matter experts (SMEs).
• Complex Problem Solving: Apply critical thinking to resolve legacy/aged CAPAs, complex complaint investigations, and field actions.

• Education: Level 8 degree in Life Sciences, Engineering, Quality Assurance, or a related technical discipline.
• Experience: 5+ years of quality or regulatory experience within a highly regulated manufacturing environment (Medical Devices / Diagnostics preferred).
• Technical Expertise: Proven track record of independently leading supplier audits and reviewing Technical Documentation for MDR/IVDR compliance.
• Travel Availability: Ability to travel 40–50% globally to conduct on-site supplier assessments.