Technical Research Regulatory Affairs Specialist/SME-FDA

Eagle Global Scientific, LLC; Dayton (OH); Remote; USD 60,000 - 100,000; Part time

Job summary

An established industry player is looking for a Technical Research Regulatory Affairs Specialist/SME to join their team. This part-time remote position focuses on ensuring compliance with FDA regulations in clinical research. The ideal candidate will have extensive experience in FDA regulatory affairs, including conducting audits and developing training materials. This role offers the opportunity to contribute to innovative research projects while working flexibly from home. If you have a passion for regulatory compliance and a desire to make a difference in the field of medical devices, this position is perfect for you.

Qualifications

• 5+ years in FDA research regulatory affairs.
• Experience in FDA clinical research protocol compliance.
• Bachelor's degree in technical science or engineering.

Responsibilities

• Manage FDA regulatory affairs for clinical trials.
• Conduct regulatory audits and compliance reviews.
• Develop training materials for FDA regulations.

Skills

FDA research regulatory requirements

Clinical research protocol compliance

Regulatory affairs quality assurance audits

Consultation on FDA-regulated device research trials

Development of training materials

Microsoft Office Suite (Word, PowerPoint, Excel)

Education

Bachelor’s Degree in a technical science, engineering or medical area

Regulatory Affairs Professional certification (preferred)

Tools

Microsoft Word

Microsoft PowerPoint

Microsoft Excel

Cloud-based research protocol management systems

Job description

Technical Research Regulatory Affairs Specialist/SME-FDA

Thursday, April 3, 2025

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:
• 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.

Highly Desired Qualifications:
• 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.