Senior Regulatory Affairs Professional

Versiti, Inc.•Dayton, OH

12d•Hybrid

About The Position

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.

Requirements

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

Nice To Haves

Master's Degree preferred
Experience in QMS, QA, QC, or Quality Auditing preferably in an environment such as blood banking, pharmaceutical, medical devices, or a hospital, preferred
Advanced knowledge of GxP requirements such as Good Documentation Practice (GDP) and FDA Quality System Regulations (QSR) preferred
Quality Certifications highly preferred (i.e., ASQ CQA, ASQ CMQ/OE, RAPS RAC) preferred

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.
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.