Top 35 Radiological Safety Analyst Jobs

Sr. Regulatory Affairs Analyst - Medical Devices
Tunnell Government Services —Washington, DC
- Remote
- Senior level
- Leadership
- Communication skills
Quick Apply
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Battelle —Washington, DC
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Radiation Safety Program Analyst
SAIC —Kirtland AFB, NM
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1d
International Programs Analyst
Analytic Services Inc —Arlington, VA
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Lawrence Livermore National Laboratory —Livermore, CA
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9d
Senior/Principal ES&H Compliance and Assurance Analyst - Regulatory Support Program, Hybrid
Sandia National Laboratories —Albuquerque, NM
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- 5 years
- Pass drug screening
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9d
Operations Research Analyst - Systems Engineering
Systems Planning and Analysis —Alexandria, VA
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- Microsoft Excel
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Sr. Operations Research Analyst - Systems Engineering
Systems Planning and Analysis —Alexandria, VA
- $160,000 - $190,000 a year
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Nuclear Criticality Safety Engineer
ENERCON Services —Oak Ridge, TN
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Quick Apply
Application Support Analyst I for Dentistry
UTHealth Houston —Houston, TX
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2d
Probabilistic Risk Analyst/Modeler
Battelle —Crystal City, VA
- $155,000 - $220,000 a year
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Environmental Health Specialist I
County of Monterey, CA —Salinas, CA
- $5,365.53 - $7,327.67 a month
- Weekends as needed
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Biomedical Equipment Planning and Contract Analyst
Akron Children's Hospital —Akron, OH
- Full-time
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Environmental Health Specialist I
County of Monterey —Natividad, CA
- $30.96 - $42.28 an hour
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Program Analyst III - SOF
TI VERBATIM CONSULTING INC —Stafford, VA
- $85,000 - $95,000 a year
- Full-time
- Microsoft Excel
- Microsoft Outlook
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3d
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Amentum —Reston, VA
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4d
Radiologic Technologist (Madras) Part-Time
Department of Corrections —Madras, OR
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8d
Sheriff's OES Analyst I/II GF
Tuolumne County —Tuolumne County, CA
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3d

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Sr. Regulatory Affairs Analyst - Medical Devices

Tunnell Government Services -
Washington, DC

Quick Apply

Job Details

Qualifications

Developing medical devices
Meeting minutes
FDA submissions
Contract documentation review
Contract review
Wearables
Contract performance monitoring
Regulatory legal research
Clinical research protocol review
Vendor compliance audits
White papers
Supplier audits
Bidding project phase
Vendor performance evaluation
Laboratory regulatory affairs
Product development
Master of Science
Procurement contract management
Vendor communication
CLIA regulations
Vendor quality assurance
Compliance support tasks
Regulatory submission editing and review
Biomedical regulatory compliance
Communication with regulatory authorities for clinical trials
Request for proposal
Procurement contract negotiation
Senior level
Cross-functional collaboration
Leadership

Full Job Description

Tunnell Government Services, Inc., is comprised of the industry's leading scientists, medical and technical experts, and human capital and organizational development professionals. We approach all projects as a team and are committed to helping our clients transform and quickly achieve strategic goals. If you are interested in joining an employee-owned company that develops and implements innovative, integrated and differentiated solutions, please click on the links below to find the job that is right for you and contact us.

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.

Tunnell strives to hire and retain the most qualified talent. We believe that having employees with different backgrounds and capabilities contributes to the success of our business. To attract qualified applicants, Tunnell posts to a wide variety of job sites. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.

Please be advised that certain client contracts may outline specific requirements for onsite work. Tunnell employees and/or contractors are expected to comply with all client requirements, including any safety and health protocols.

Quick Apply

Refine Your Search

Radiological Safety Analyst jobs

Sr. Regulatory Affairs Analyst - Medical Devices

Radiological Laboratory Technician/Data Analyst

Logistician II - Supply Chain Analyst

CBRN Analyst

Radiation Safety Program Analyst

International Programs Analyst

Waste Characterization Analyst

Senior/Principal ES&H Compliance and Assurance Analyst - Regulatory Support Program, Hybrid

Operations Research Analyst - Systems Engineering

Sr. Operations Research Analyst - Systems Engineering

Nuclear Criticality Safety Engineer

Application Support Analyst I for Dentistry

Probabilistic Risk Analyst/Modeler

Environmental Health Specialist I

Biomedical Equipment Planning and Contract Analyst

Environmental Health Specialist I

Program Analyst III - SOF

Counterterrorism Analyst Senior

Radiologic Technologist (Madras) Part-Time

Sheriff's OES Analyst I/II GF

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