Regulatory Assurance & Compliance Manager

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 DPTs 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.

Qualifications :

• Education: Bachelors degree in science-related field. (e.g. Laboratory Science Biology Chemistry or related field. ) A masters 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. 

Additional Information :

Compensation:

• $10000-$120000 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.

Remote Work :

No

Employment Type :

Full-time