Regulatory Assurance & Compliance Manager

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 Assurance/Compliance Manager is responsible for ensuring that all laboratory processes. procedures, and outputs meet defined standards of quality, regulatory compliance and patient safety. This role is critical in maintaining accreditation and delivering accurate and reliable test 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. 

Key Responsibilities:

• Regulatory Oversight & Liaison: Ensure alignment with relevant regulatory bodies (e.g., CLIA, CAP, ISO, FDA) Monitor the effectiveness of the QMS through internal audits, indicators, and reviews. Prevent fraud, abuse and negligence. Act as the primary point of contact and liaison for all regulatory and accrediting bodies (e.g., CLIA, CAP, FDA, ISO standards). Coordinate and facilitate all external inspections and audits.
• Governance and Reporting: Reports regularly to executive leadership. Develops and prepares compliance dashboards. Keeps up-to-date with FDA and state enforcement trends.
• 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.
• Quality Metrics and Performance Monitoring: Develops and analyzes trends and works collaboratively to implement process improvements. Provides KPI metrics to drive improvement.
• Policy and Procedure Development: Develop, review, revise, and implement comprehensive policies, and standard operating procedures (SOPs) to ensure ongoing compliance with evolving regulations.
• Auditing and Monitoring: Plans, schedules and conducts internal quality audits to assess compliance. Identify nonconformities and work with departments to develop corrective/preventive actions. Maintains audit records and follow up on findings. Conduct regular internal audits and risk assessments to monitor adherence to established policies and identify potential areas of non-compliance. Manage the investigation and resolution of any compliance issues or incidents. Perform RA/QA review and disposition of qualification records (plans/protocols, final reports, deviations) for compliance and accuracy in accordance with DPT’s Master Validation Plan and applicable regulatory requirements.
• Training and Education: Design and deliver ongoing training programs for all laboratory staff on critical regulatory requirements. Assists laboratory management with tools for ensuring staff training and competency assessments are current and documented.
• Safety and Risk Management: Collaborate with the Safety Officer to ensure a safe working environment and full compliance with all health and safety standards, including a chemical hygiene plan and bloodborne pathogen standards. 
• Continuous Quality Improvement: Leads or participates in quality improvement projects. Encourages a culture of quality and safety within the lab.
• Business Continuity and Corporate Liaison. Develops, executes, manages and revised effective proactive Business Continuity and Quality Risk strategies and plans for the DPT network of laboratories. DPT point person for corporate continuity efforts and disaster preparedness processes, procedures and exercises.

• Education: Bachelor’s degree in science-related field. (e.g., Laboratory Science, Biology, Chemistry or related field. ) A master’s degree or professional certification (e.g., Certified Regulatory Compliance Manager (CRCM) or ASQ certification) preferred.
• Experience: A minimum of 3-5 years of experience in a laboratory setting with significant experience overseeing quality assurance and regulatory compliance programs.
• Knowledge: In-depth knowledge of relevant federal, state, and local regulations and standards (e.g., CLIA, CAP, FDA, ISO 15189, GxP).
• Analytical Skills: Strong analytical and problem-solving abilities to evaluate data, identify risks, and develop effective solutions.
• Communication: Excellent written and verbal communication skills, with the ability to effectively communicate complex technical and regulatory information to diverse stakeholders and regulatory bodies.
• Leadership: Proven leadership skills to direct staff, manage projects, and foster a strong culture of compliance and continuous improvement.
• Organizational Skills: Exceptional attention to detail, organization, and time-management skills to manage multiple priorities and deadlines effectively. 

Compensation:

• $100,00-$120,000 per year

Schedule:

• Monday - Friday 8:00am-4:30pm

What we offer:

• Excellent full time benefits including comprehensive medical coverage, dental, and vision options
• Life and disability insurance
• 401(k) with company match
• Paid vacation and holidays

Eurofins USA Clinical Diagnostics is a Disabled and Veteran Equal Employment Opportunity employer.