Sr. Regulatory Affairs SME - Medical Devices

Background: A Regulatory Affairs Analyst/subject matter expert is needed to provide contracted staffing support to the Biomedical Advanced Research and Development Authority (BARDA), within the U.S. Department of Health and Human Services in Washington, DC. The mission of BARDA is to develop and procure medical countermeasures that address the public health and medical consequences of chemical, biological, radiological, and nuclear (CBRN) accidents, incidents and attacks, pandemic influenza, and emerging infectious diseases (EID). Specifically, BARDA supports the advanced development and procurement of drugs, vaccines and other products that are considered priorities for national health security. For more information on BARDA please visit their website at: https://aspr.hhs.gov/AboutASPR/ProgramOffices/BARDA/Pages/default.aspx and specifically the Division of Regulatory and Quality Affairs: https://medicalcountermeasures.gov/barda/rqa

Duties of the position: This position will serve as regulatory affairs subject matter expert for multiple BARDA programs and projects involving development and manufacturing of in vitro diagnostic and device medical countermeasures specific to influenza, emerging infectious disease, CBRN threats (e.g. anthrax, filovirus, burn/blast trauma assessment, etc.), sepsis, and digital health technologies. These are products which are regulated by FDA's Center for Devices and Radiological Health (CDRH) and/or combination products crossing multiple centers. This technical advisory support covers the entire range from the inception of requirements to placing FDA cleared or approved products into the Strategic National Stockpile. Specific duties may include but are not limited to:

• Provide regulatory affairs expertise and guidance for assigned programs and projects
• Monitor 21CFR compliance on assigned programs and projects
• Support BARDA in the review of contract-related documents, including regulatory strategy, development plans, study reports, study protocols and progress reports
• Review and provide feedback on contractor FDA submissions, which may include IDEs, Pre-submissions (Q-subs), Premarket Submissions (510(k)), Premarket Applications (PMA), CLIA waivers etc.
• Assist in preparation for contractor submission meetings with FDA, as assigned.
• Attend contractor submission meetings with FDA and interpret FDA feedback as appropriate
• Monitor BARDA supported contractors' project timelines for key regulatory and quality performance measures, and provide recommendations to overcome challenges and reduce program risk
• Participate in site visits/audits to review and monitor vendor progress toward completion of contract milestones
• Assist Project Team and BARDA supported contractors to develop and manage strategy, protocols and FDA applications for Emergency Use Authorizations
• Participate or act as regulatory representative on various cross-functional teams, as assigned
• Maintain current knowledge of the US competitive landscape, regulatory environment, regulations and guidance
• Provide regulatory opinions on specific issues
• Support contract initiation/negotiation efforts by providing regulatory and quality assessments of white papers and proposals to BARDA
• Provide regulatory expertise on draft Statements of Work (SOW) for upcoming Requests for Proposals (RFP) and support technical and cost evaluation for white papers/proposals
• Draft meeting minutes, trip reports, and technical assessments and recommendations (including regulatory opinions) on the regulatory aspects of BARDA-contractor interactions

Education:

• M.S. or higher in life sciences or related field is highly preferred

Desired Experience:

• Minimum 15 years of device development; Government or industry experience in regulatory and/or quality affairs for diagnostic devices, particularly seeking expertise with imaging devices, software as a medical device, in vitro diagnostic devices, wearable technologies, digital health, and home use diagnostics.
• Experienced in addressing FDA/CDRH hurdles (especially during late stage product development)
• Experience in identifying and resolving quality, regulatory, clinical or process development problems for medical devices
• Excellent people and communication skills, with a team-oriented leadership style

Must be US Citizen or Full Green Card holder.