Careers in Quality

Donor Alliance is hiring a Regulatory Affairs Coordinator in Denver! The Regulatory Affairs Coordinator works closely with the Director of Quality Systems to provide comprehensive monitoring and analysis of current and impending regulations/standards.  This position is responsible for performing audits, reviewing software validation scripts and internal testing, and performing validations/verifications.  In addition, the Regulatory Affairs Coordinator collaborates with the leaders within the organization to ensure compliance with regulatory, accreditation, and legislative standards.  This position interacts with all levels of employees to promote quality systems, continuous quality improvement, and regulatory compliance related to organizational goals and industry standards

Day-To-Day

• Facilitates compliance with all regulatory agencies in conjunction with appropriate leaders of the organization. Monitors and analyzes changes in legislation and accreditation standards that affect Donor Alliance operations, including but not limited to the FDA, AATB, AOPO, CMS, and UNOS, and makes recommendations for internal changes.
• Plans, implements and manages Donor Alliance audits. Functions as lead for internal and supplier/vendor audits, and assists with preparation for onsite agency inspections and accreditation surveys as needed.  Ensures effective internal and external audit systems to maintain compliance with regulatory, accreditation, and tissue processor requirements. 
• Utilizes Donor Alliance’s CAPA, NCR, and CMR systems to ensure that events are documented and tracked, and supplier issues are monitored and closed.
• Facilitates and participates in quality improvement activities.
• Reviews, analyzes, and determines applicability and change to SOPPs that allow the organization to achieve and maintain compliance. Provides support for the review, creation, update and maintenance of organizational SOPPs.
• Coordinates and/or participates in process, software, and equipment validation, verification, and/or certifications. Maintains appropriate documentation to satisfy regulatory and accreditation requirements.
• Initiates and maintains the supplier qualification program and documentation.
• Coordinates internal deviation management, ensuring all appropriate approvals are obtained, implemented, and closed.
• Provides support for ensuring compliance with OSHA regulations. Assists in the maintenance of required documentation, including but not limited to Safety Data Sheets (SDS), biohazard disposal, policies and procedures, and safety records.
• Performs gap analysis, develops improved systems and processes, and is a resource for system improvements.
• May perform other related duties as required to meet the ongoing needs of the organization.
• Performs back-up responsibilities for the OPTN Coordinator, such as timely notification to transplant centers of positive culture results.

To apply to the Regulatory Affairs Coordinator, please click: https://jobapply.page.link/pnS9i

• Bachelor’s degree or equivalent education and work experience required.
• Minimum of three years’ experience in a healthcare setting or regulatory environment required.
• Previous experience in quality management in healthcare, including experience with managing audits, preferred.
• Experience with the FDA is strongly preferred.
• American Association of Tissue Bank (AATB) Certification as a Certified Tissue Bank Specialist (CTBS) required within 18 months of employment.
• Certification through organizations such as American Society of Quality (ASQ) or National Association for Healthcare Quality (NAHQ) is strongly preferred.
• Previous experience in quality improvement tools
• Excellent verbal and written communication skills, with public speaking experience strongly preferred.
• Strong interpersonal skills and ability to apply consistent standards with flexibility for department functions required.
• Proficiency in the use of computer equipment and software, including but not limited to, Windows environment (Word, Excel, PowerPoint – Intermediate to Advanced skills) required.