Regulatory Affairs Coordinator - Clinical Laboratory

Position Summary / Career Interest:

The Regulatory Affairs Coordinator for the Laboratory ensures compliance with all federal, state, and local regulations that govern laboratory operations. The role supports regulatory and accreditation submissions, maintains documentation, collaborates with various departments to uphold quality standards, and oversee the lab safety program for the entire lab system.

Responsibilities and Essential Job Functions

• 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.
• These statements are intended to describe the essential functions of the job and are not intended to be an exhaustive list of all responsibilities. Skills and duties may vary dependent upon your department or unit. Other duties may be assigned as required.

Required Education and Experience

• High School Graduate
• Bachelor of Science

Preferred Education and Experience

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

Required Language Skills

• Fluent English -

Knowledge Requirements

• Takes responsibility for self and/or team accountabilities and instills sense of ownership in others to improve performance; looks for ways to improve individual and/or team performance
• Proficient in utilizing technology and Microsoft Office products.
• Excellent communication, writing, organization, and presentation skills.

We are an equal employment opportunity employer without regard to a person’s race, color, religion, sex (including pregnancy, gender identity and sexual orientation), national origin, ancestry, age (40 or older), disability, veteran status or genetic information.