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
General Job Description
The Regulatory Affairs (RA) Coordinator is responsible for ensuring the laboratory stays compliant with all regulatory, licensing, and accreditation requirements (e.g., CLIA, CAP, State DOH, FDA, ASHI, TGA, GHA, ISO 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 improvement initiatives within the laboratory setting.
Key Responsibilities
Regulatory Compliance and Monitoring
- Interprets and applies federal, state and local regulations and accreditation standards to laboratory operations.
- Regularly reviews and monitors evolving regulatory requirements and guidelines, implementing changes to ensure ongoing compliance.
Maintain Regulatory Readiness
- Maintains and tracks all necessary licenses, registrations and certifications for the laboratory and its testing activities.
- Maintains a calendar of inspection dates and licensing renewals.
- Manages and renews CLIA Certificates, State Lab Licenses, CAP and ASHI Accreditation paperwork, FDA Registrations.
- Maintains accurate facility, personnel, and test menu information in regulatory systems.
- Conducts readiness reviews and gap analyses in advance of inspections.
Audits and Inspections
- Coordinates and participates in external audits and inspections from regulatory/accrediting bodies (e.g., FDA, CAP, CLIA, etc.) and/or clients.
- Coordinates post-inspection responses and CAPAs with QA and leadership.
- Coordinates the Internal Audit schedule and assigns auditors as necessary to meet the scope and expectations of the schedule.
- Performs internal audits in auditor or lead auditor role to evaluate compliance and identify potential risks or noncompliance issues.
Policy and Document Control
- Ensure SOPs and policies are aligned with regulatory standards.
- Participates in SOP review cycles.
- Assists in aligning technical and administrative documents to agencies (e.g., CAP or ASHI Checklists, FDA expectations).
Reporting and Compliance Metrics
- 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 dashboards or trackers for:
- Licensing statuses
- Inspection readiness
- Audit findings and CAPA statuses
Training and Education
- Provide training and support to inter and intra departmental employees particularly of applicable regulatory standards as well as other Quality System elements including, but not limited to, organizational-wide training (e.g., Annual GMP Training), Good Documentation practices (GDP), Good Tissue Practices, Investigations, QMS components, Document & Record Management, Training Program.
Problem Solving and Improvement
- Investigate incidents, nonconformances, and vendor recall notices, communicating findings and resolutions to stakeholders.
- Serves as a consultant for internal and external customers; assist RA/QA management in addressing business needs in regulatory area by guiding identification of cause, finding best solution, supporting implementation and monitoring.
Additional Responsibilities
- In order to meet Eurofins DPT’s quality policy and goals/objectives, all employees are expected to meet basic expectations of Eurofins DPT’s quality management system including, but not limited to good workmanship, adherence to standard operational procedures, training, good documentation practices, and accurate recordkeeping.
- Exhibit support of Eurofins DPT’s business philosophy, leadership values, quality objectives, ethical behaviors, customer care and confidentiality standards at all times. Foster a positive work environment, modeling professional behavior.
- Pursue and actively participate in professional growth and development opportunities as they relate to and benefit the position and organization.
Qualifications
Minimum Educational Requirements
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.
Preferred Qualifications
- Certification in quality management (e.g., Certified Quality Auditor (CQA) or Six Sigma certification).
- 5-7 years of experience with regulatory and/or accrediting agencies (e.g. FDA, ISO, ASHI, CLIA).
Skills
- Excellent attention to detail and strong organizational skills.
- Strong analytical and problem-solving abilities, with an aptitude for data interpretation and statistical analysis.
- Excellent written and verbal communication skills, with the ability to effectively communicate with diverse staff and management.
- Proficiency with laboratory information management systems (LIMS) and Microsoft Office Suite.
- Ability to work both independently and collaboratively in a fast-paced environment.
Potential Environmental Factors
- This laboratory carefully maintains all hazardous materials. All employees must abide by Eurofins DPT’s Safety and Exposure procedures. This includes using the provided safety clothing and equipment.
- For a list of potential chemical hazards, see appropriate SDS sheet.
Additional Information
Compensation:
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.