Company Description
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.
Job Description
The Regulatory Assurance Coordinator is responsible for ensuring the laboratory stays compliant with all regulatory, licensing, and accreditation requirements (e.g., CLIA, CAP, State DOH, FDA, etc.). This role focuses specifically on regulatory readiness, documentation and inspection support. This role involves ensuring adherence to all relevant standards, managing documentation, facilitating audits, and driving continuous quality improvement initiatives within the laboratory setting.
Key Responsibilities
- Regulatory Compliance & Monitoring:
- Interpret and apply federal, state, and local regulations and accreditation standards to laboratory operations.
- Regularly review and monitor evolving regulatory requirements and guidelines, implementing changes to ensure ongoing compliance.
- Maintain and track all necessary licenses, registrations, and certifications for the laboratory and its testing activities.
- Conducts readiness reviews and gap analyses in advance of inspections
- Quality Management System (QMS):
- Ensure SOPs and policies are aligned with regulatory standards.
- Participate in SOP review cycles.
- Assist in aligning technical and administrative documents to CAP checklists or FDA expectations.
- Audits & Inspections:
- Coordinate and serve as the primary liaison and host for external client audits, regulatory and accreditation inspections (e.g., FDA, CAP inspections).
- Conduct regular internal audits and assessments to evaluate compliance and identify potential risks or non-compliance issues.
- Track corrective and preventative actions (CAPA) resulting from audits or incidents, ensuring timely and effective resolution and documentation.
- Coordinate post-inspection responses and CAPAs with QA and leadership.
- Data Management & Reporting:
- Maintain dashboards or trackers for:
- Licensing status
- Inspection readiness
- Aduit findings and action plan (corrective/preventive) statuses
- Collect, compile, and analyze quality data to identify trends, issues, and improvement opportunities.
- Prepare clear and comprehensive reports on quality metrics, audit findings, and compliance status for laboratory management and directors.
- Maintain accurate and organized documentation and records in a survey-ready state.
- Training & Education:
- Assist in the monitoring of staff training and competency assessment programs.
- Provide guidance and support to laboratory personnel on regulatory matters, quality standards, and safety protocols.
- Problem Solving & Improvement:
- Investigate incidents, non-conformances, and vendor recall notices, communicating findings and resolutions to stakeholders.
- Utilize quality improvement expertise and tools (e.g., root cause analysis) to facilitate best practice development and process improvements.
Qualifications
- Education: A Bachelor's degree in a relevant scientific field (e.g., Medical Technology, Clinical Laboratory Science, Chemistry, Biology) is typically required.
- Experience: 2-5 years of experience in a laboratory setting with specific experience in quality assurance and/or regulatory affairs.
- Knowledge: Extensive knowledge of laboratory regulations (e.g., CLIA, CAP, FDA,) and quality control principles.
- Skills:
- Strong organizational skills and meticulous attention to detail.
- Excellent written and verbal communication skills, with the ability to interpret and explain complex regulations.
- Strong analytical and problem-solving abilities.
- Proficiency with laboratory information management systems (LIMS) and Microsoft Office Suite.
- Ability to work both independently and collaboratively in a team environment.
Preferred Qualifications
- Certification in quality management (e.g., ASQ certification).
- Familiarity with electronic document control systems.
Compensation
Additional Information
- $85,000 - $105,000 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.
