Senior Regulatory Affairs Professional

Quality Department Senior Member

This role provides advanced support to the Quality department in the area(s) of regulatory affairs and acts as a senior member of the Quality team to meet the goals and objectives of the department and potentially other service lines. This role supports the overall quality program and serves as a liaison between the Regulatory Affairs/Quality team and other service lines of Versiti. He/she/they partners with service lines to provide regulatory affairs input on projects and everyday tasks.

Core Quality Responsibilities:

• Supports Manager in executing the Quality Plan and ensuring compliance with applicable regulations and standards.
• Integrates continuous improvement practices adopted by Versiti into quality systems, education, and improvement activities.
• Supports internal/external assessments as assigned and facilitates optimal communication between the department and the inspector/assessors.
• Reviews charts, tables, etc. to analyze quality metrics. Identifies areas requiring action based on quality metrics. Communicates and works collaboratively with service lines to develop appropriate actions.
• May review and approve standard operating procedures, validation plans and results, corrective action plans associated with events, and other required documents for regulatory affairs, as required.
• Reviews regulatory and standards changes/updates for impact on existing processes. Communicates changes/updates to service line management.
• Participates and may lead in the development, compilation, and submission of regulatory submissions as required.
• May review, analyze, approve, and monitor events logged in event management system, including adequacy of investigation, quality of documentation, and appropriateness of corrective and preventative actions.
• Completes the review of events to assess impact.
• Acts a resource for regulatory and quality matters.

Specific Senior Regulatory Affairs (RA) Specialist Responsibilities:

• Authors and prepares documentation for regulatory submissions.
• Provides internal and external regulatory guidance and development of regulatory strategies.
• Maintains awareness of changes in global regulatory requirements for effective regulatory submissions and production documentation.
• Maintains facility registrations for Versiti.
• Review documentation and make determination of submission to regulatory agencies, as applicable.
• Coordinates and consults with other functions on the content and assembly of regulatory documentation and ensures consistency, completeness, and adherence to standards for all the regulatory submission.
• Support regulatory compliance activities, including manufacturing site registration, audits, etc., as needed.
• Leads and tracks regulatory projects.
• Support junior-level RA Specialists in project execution and/or day-to-day RA tasks.

Performs other duties as assigned. Complies with all policies and standards.

Education:

• Bachelor's Degree (in Clinical Laboratory Science, life sciences, engineering with science minor, scientific discipline, or allied health science discipline) required.
• Master's Degree preferred.

Experience:

• 4-6 years of experience in related field required.
• 4-6 years of experience with a master's degree required.
• Experience in Regulatory Submissions and facility registrations required.
• Experience in QMS, QA, QC, or Quality Auditing preferably in an environment such as blood banking, pharmaceutical, medical devices, or a hospital, preferred.

Knowledge, Skills and Abilities:

• Advanced knowledge of the principles and practices within Regulatory Affairs (requiring academic preparation and experience).
• An experienced professional qualified in Regulatory Affairs, and possess experience in other complex technical area(s).
• Requires advanced knowledge and application of external standards and regulations that impact related disciplines.
• Determines and implements a course of action based on regulations, standards, and guidelines, and may modify processes and methods as required.
• Requires knowledge of company policies, practices, and procedures or ability to quickly gain applicable knowledge.
• Require knowledge and application of external standards and regulations.
• Ability to use professional concepts and company's policies and procedures to solve a variety of problems.
• Strong written communication and business acumen skills.
• Proficiency in Microsoft Office.
• Possess strong attention to detail.
• Ability to read, interpret and disseminate applicable regulations and standards.
• Advanced knowledge of GxP requirements such as Good Documentation Practice (GDP) and FDA Quality System Regulations (QSR) preferred.

Licenses and Certifications:

• Quality Certifications highly preferred (i.e., ASQ CQA, ASQ CMQ/OE, RAPS RAC) preferred.

Tools and Technology:

• Personal Computer (desktop, laptop, tablet) required.
• General office equipment (computer, printer, fax, copy machine) required.
• Microsoft Suite (Word, Excel, PowerPoint) required.
• Gap Assessment Tools for Standards/Regulations required.