...ECMO, massive transfusion protocols, and adult/pediatric ICU patients. The Blood Bank and Transfusion Medicine are inspected by the FDA, AABB and CAP agencies. The Cellular Therapies Laboratory oversees the processing, storage, and characterization of cellular therapy...
Suggested
Permanent employment
Local area
Shift work
Day shift
Monday to Friday
...documents including study reports and method validations
* Work together with regulatory team to prepare documents to submit to the FDA
This full-time position requires:
* BS/MS graduate with some immunology and bacteriology background.
* Expertise with sterile...
Suggested
Full time
...models. Prior experience in leading SBIR/STTR sponsored studies is preferred. Knowledge on therapeutic development and communication with FDA for regulatory guidance will be valuable for this position.
Interested individuals may apply at Please provide a cover letter,...
Suggested
Part time
Remote job
Outdoor
...hazards, 5) National Regulatory Commission requirements for the handling, storage, security, and disposal of radioactive materials, 6) FDA-approved medical products with potential application for treatment and/or prevention of chemically induced injury, 7) the latest...
Suggested
...store and ship laboratory specimens as necessary.
* Prepare and submit necessary documents for Institutional Review Boards (IRB), FDA, National Institutes of Health (NIH) or Data Safety Monitoring Board (DSMB) review; document and report protocol deviations.
* Able...
Suggested
Local area
Work visa
...other study team members on clinical research projects assigned.
* Demonstrate a working knowledge of the regulatory framework for FDA and non-FDA regulated studies.
* Work well with minimal supervision as appropriate.
* Facilitate and / or complete activities required...
Suggested
Full time
Traineeship
Work visa
Flexible hours
...designer, manufacturer, and distributor of world-first, imaging-based medical solutions based in Charlottesville, VA. RIVANNA operates an FDA-registered and ISO 13485:2016 certified manufacturing facility where it produces the Accuro® product line and related medical...
Suggested
Work experience placement
Local area
...experience
~ Experience and training to MDSAP, ISO 13845, and IEC60601
~ External audit management experience
~ Experience with FDA pre-submissions and 510(k) applications
Responsibilities
Actively manage and improve the company’s MDSAP and ISO 13485-certified...
Suggested
Local area
...progress and ensure continuity of care.
Identifying and resolving any issues related to patient discomfort during treatment using FDA pre-approved guidance from device manufacturer(s) or applicable medication protocols and in accordance with all clinical provider directives...
Suggested
Full time
Work experience placement
Local area
Relocation bonus
Flexible hours
Shift work
Monday to Friday
...Principal/Sub Investigators conducts the following according to the study protocol, company processes & procedures, and in compliance with FDA, GCP, and ICH regulations and guidelines. The Clinical Research Coordinator (CRC) works to ensure the execution of assigned studies...
Suggested
Full time
Temporary work
...other study team members on clinical research projects assigned.
* Demonstrate a working knowledge of the regulatory framework for FDA and non-FDA regulated studies.
* Work well with minimal supervision
* Facilitate and / or complete activities required for study...
Suggested
Full time
Traineeship
Work visa
Flexible hours
Weekend work
...designer, manufacturer, and distributor of world-first, imaging-based medical solutions based in Charlottesville, VA. RIVANNA operates an FDA-registered and ISO 13485:2016 certified manufacturing facility where it produces the Accuro® product line and related medical...
Suggested
...manipulation, pushing and pulling.
* Work requires the following motions: bending, twisting, squatting and reaching.
* Exposure to FDA approved cleaning chemicals.
* Exposure to temperatures: 90 degrees Fahrenheit.
* Ability to work in a wet and cold environment....
Suggested
Holiday work
Full time
Flexible hours
Night shift
...budgeting and billing to facilitate compliance with all relevant laws, regulations, and policies.
* Maintain understanding of CMS and FDA regulations relevant to Medicare coverage analysis, as well as other regulations pertaining to conducting a clinical trial, including...
Suggested
Remote job
...manipulation, pushing and pulling.
work requires the following motions: bending, twisting, squatting and reaching.
exposure to fda approved cleaning chemicals.
exposure to temperatures: 90 degrees fahrenheit.
ability to work in a wet and cold environment....
Suggested
Holiday work
Full time
Part time
Flexible hours
Night shift
...Performs all mammography tracking following MQSA guidelines and requirements.
Maintains all QA documents necessary to exceed Annual FDA Inspection requirements.
Is responsible for obtaining and maintaining ACR accreditation.
Exceptional compensation for the right...
Flexible hours
Weekend work
Afternoon shift
...their personal dietary needs & campus housing location & accommodations
Food and Safety Oversight Oversees compliance for the U.S. FDA menu labeling laws as it relates to recipe & menu board signage in on-campus residential and proprietary retail locations, C-stores,...
Permanent employment
Flexible hours
...manipulation, pushing and pulling.
Work requires the following motions: bending, twisting, squatting, and reaching.
Exposure to FDA approved cleaning chemicals.
Exposure to temperatures: 90 degrees Fahrenheit.
Ability to work a flexible schedule including...
Holiday work
Part time
Seasonal work
Flexible hours
Shift work
Night shift
Sunday
Saturday
...manipulation, pushing and pulling.
Work requires the following motions: bending, twisting, squatting and reaching.
Exposure to FDA approved cleaning chemicals.
Exposure to temperatures: 90 degrees Fahrenheit.
Ability to work in wet and dry conditions.
Ability...
Holiday work
Full time
Work experience placement
Immediate start
Flexible hours
Shift work
Night shift
All shifts
...manipulation, pushing and pulling.
~ Work requires the following motions: bending, twisting, squatting and reaching.
~ Exposure to FDA approved cleaning chemicals.
~ Exposure to temperatures: Less than 32 degrees Fahrenheit (freezing), 32-40 degrees Fahrenheit (...
Holiday work
Full time
Part time
Work experience placement
Immediate start
Currently hiring
Flexible hours
Shift work
Night shift
Day shift
All shifts
...manipulation, pushing and pulling.
Work requires the following motions: bending, twisting, squatting, and reaching
Exposure to FDA approved cleaning chemicals
Exposure to temperatures 90 degrees Fahrenheit
Ability to work in a wet and cold environment.
Ability...
Holiday work
Flexible hours
Night shift
...Performs all mammography tracking following MQSA guidelines and requirements.
Maintains all QA documents necessary to exceed Annual FDA Inspection requirements.
Is responsible for obtaining and maintaining ACR accreditation.
Exceptional compensation for the right...
Part time
Flexible hours
Weekend work
1 day per week