Senior Regulatory Affairs Professional

Versiti is a fusion of donors, scientific curiosity, and precision medicine that recognize the gifts of blood and life are precious. We are home to the world-renowned Blood Research Institute, we enable life saving gifts from our donors, and provide the science behind the medicine through our diagnostic laboratories. Versiti brings together outstanding minds with unparalleled experience in transfusion medicine, transplantation, stem cells and cellular therapies, oncology and genomics, diagnostic lab services, and medical and scientific expertise. This combination of skill and knowledge results in improved patient outcomes, higher quality services and reduced cost of care for hospitals, blood centers, hospital systems, research and educational institutions, and other health care providers. At Versiti, we are passionate about improving the lives of patients and helping our healthcare partners thrive.

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.

• →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

• 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

• 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

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

• 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

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