What are the responsibilities and job description for the Technical Research Regulatory Affairs Specialist/SME-FDA position at BRS?
Eagle Global Scientific is seeking a Technical/Research Regulatory Affairs Specialist/Subject Matter Expert for Food and Drug Administration (FDA) (Part-Time, Remote)
Mandatory Qualifications:
Mandatory Qualifications:
- Contractor shall have at least 5 years’ experience applying FDA research regulatory requirements within a research regulatory affairs program office. Work in preparing one’s own research proposals and one’s own submissions to an IRB office or to the FDA and managing one’s own research portfolio will not meet the qualifications required by this section.
- 3 years current (within the past 5 years) personal and direct experience in FDA clinical research protocol compliance administration and shall have personally conducted FDA focused regulatory affairs quality assurance audits of customer’s research projects.
- Bachelor’s Degree in a technical science, engineering or medical area. Shall meet all technical and experience prerequisites to be qualified to test for Regulatory Affairs Professional certification, such as Certified Clinical Research Professional (CCRP), Research Regulatory Affairs Professional (RAP) or other like-kind industry standard certification. Current holder of regulatory affairs professional certification is preferred.
- At least 1 year current (within the past 3 years) prior experience in developing or providing detailed consultation on the development of FDA-regulated device research trials, including, but not limited to research involving software as a medical device (SaMD), off-label research use of FDA-controlled medical devices, and bio-sensing wearable devices.
- Contractor shall have prior experience either reviewing applications submitted to the FDA CDRH , or as a Sponsor preparing and submitting to the FDA for FDA-regulated devices for FDA review, determinations, or approval.
- Contractor shall have prior experience in the development, planning, hosting and delivering FDA research regulatory affairs training and education materials, including but not limited to web-site materials, workshops, training presentations, and quality assurance visits and discussions related to administration of clinical trial research records.
- Contractor shall have knowledge, skill, training, experience and ability to be proficient in the use of desktop computer workstation for accomplishment of tasks in Microsoft Word, Microsoft PowerPoint, Excel, as well as internet applications including e-mail, worldwide web searches, electronic based research, web-page maintenance, and cloudbased/web-based research protocol management systems.
- Experience working directly for a Department of Defense research regulatory affairs program office. Or experience working with FDA Center for Devices and Radiological Health (CDRH).
- Experience with the technical review and FDA research compliance review of nonclinical warfighter operational health and performance biosensing and human wearable bio-devices.
