Manager, Regulatory Affairs and Compliance

Eurofins Scientific is an international life sciences company, providing a unique range of analytical testing services to clients across multiple industries, to make life and our environment safer, healthier and more sustainable. From the food you eat, to the water you drink, to the medicines you rely on, Eurofins works with the biggest companies in the world to ensure the products they supply are safe, their ingredients are authentic and labelling is accurate.

Eurofins is the global leader in food, environment, pharmaceutical and cosmetic product testing and in agroscience Contract Research Organisation services. Eurofins is one of the market leaders in certain testing and laboratory services for genomics, discovery pharmacology, forensics, advanced material sciences and in the support of clinical studies, as well as having an emerging global presence in Contract Development and Manufacturing Organisations.

The Group also has a rapidly developing presence in highly specialised and molecular clinical diagnostic testing and in-vitro diagnostic products.

In over just 30 years, Eurofins has grown from one laboratory in Nantes, France to 55,000 staff across a decentralised and entrepreneurial network of 900 laboratories in over 50 countries. Eurofins offers a portfolio of over 200,000 analytical methods to evaluate the safety, identity, composition, authenticity, origin, traceability and purity of biological substances and products.

The Regulatory Affairs / Compliance Manager is responsible for ensuring that all laboratory processes, procedures, and outputs meet defined standards of quality and regulatory compliance. This role is critical in maintaining accreditation and delivering accurate and reliable testing results. The Manager designs and implements policies and procedures, conducts regular audits, manages documentation, and leads staff training initiatives to foster a culture of compliance and maintain the highest standards of quality and safety.

This role coordinates cross-functional input.

• Regulatory Oversight: Ensures alignment with relevant regulatory / accrediting bodies (e.g., FDA, CLIA, CAP, ISO, ASHI, etc.) Monitors effectiveness of the QMS through internal audits, indicators and reviews. Prevents fraud, abuse and negligence. Acts as primary point of contact and liaison for regulatory and accrediting bodies (e.g., FDA, CLIA, CAP, ISO, FDA). Coordinates and facilitates external inspections and audits. Promotes safe and lawful operations.
  
  Ensures inspection-readiness. Supports a culture of accountability and transparency.
• Governance and Reporting: Reports regulatory to executive leadership. Prepares compliance dashboards. Maintains audit information for investigations. Keeps up-to-date with FDA and State enforcement trends.
• Vendor and Third-Party Compliance: Ensure vendors meet compliance requirements (e.g., HIPAA, FDA registration, etc.). Participates in due diligence with vendor onboarding and contract review, as appropriate.
• Risk Assessment and Incident Management: Leads compliance risk assessments, as needed. Serves as key contact for reporting compliance concerns. Investigates complaints, breaches or suspected fraud.
• Risk Management: Identifies and assesses risk to quality, employee and/or patient safety. Leads Risk Assessments / Projects to mitigate risk and improve resilience of lab processes.
• Electronic Document Management System: Collaborates with the Quality Assurance Manager in maintaining an effective and efficient electronic document management system, including the various elements (e.g., document control system, training matrix maintenance, metrics, etc.). Seeks improvements to the system and acts as Subject Matter Expert.
• Quality Metrics and Performance Monitoring: Develops and analyzes trends and works collaboratively to implement process improvements. Provides KPI metrics to drive improvement.
• Auditing and Monitoring: Plans, schedules and conducts internal quality audits to assess compliance. Identify nonconformities and works with departments to develop corrective/preventive actions. Maintains audit records and follow up on findings. Conducts regular internal audits and risk assessments to monitor adherence to established policies and identify potential areas of non-compliance. Manages the investigation and resolution of any compliance issues or incidents.
  
  Performs RA/QA review and disposition of qualification records (plans/protocols,…