Regulatory Affairs Coordinator – Clinical Laboratory

Regulatory Affairs Coordinator – Clinical Laboratory

Requirements

• High School Graduate
• Bachelor of Science
• Fluent English
• Proficient in utilizing technology and Microsoft Office products
• Excellent communication, writing, organization, and presentation skills.

Responsibilities

• Monitor and interpret regulatory changes affecting laboratory operations.
• Prepare and submit regulatory documents, including FDA, CLIA, KDHE, MDHSS applications, licenses, certifications and responses to inspections.
• Assist in the development and implementation of policies and procedures to ensure compliance with regulatory requirements.
• Develop and submit corrective action plans/reports to regulatory bodies. Monitors and reports progress.
• Conduct internal audits and participate in inspections from regulatory bodies.
• Maintain accurate records of regulatory submissions and communications.
• Collaborate with laboratory management and staff to ensure adherence to quality assurance protocols.
• Oversee the lab safety program which includes, but not limited to, leading biweekly Risk & Safety huddles, managing the MSDS and Chemical Inventories, and collaborating with EHS/IPAC to ensure compliance with safety regulations.
• Provide training and support to pathologists, residents and staff regarding regulatory compliance and best practices.
• Prepares and submits reports for regulatory agencies and management.
• Acts as a superuser of the laboratory quality management software.
• Manage delegation of duties and other required personnel documentation.
• Assists in management, completion and review of nonconforming events.
• Must be able to perform the professional, clinical and or technical competencies of the assigned unit or department.

Preferred Qualifications

• Master’s Degree
• 2 or more years laboratory regulatory and/or accreditation