CAMRIS is seeking a Medical Device Expert to join the team for a Regulatory Affairs proposal at the The Joint Program Executive Office for Chemical, Biological, Radiological, and Nuclear Defense (JPEO-CBRND) in Aberdeen, Maryland.
Reasonable Accommodation Statement:
To accomplish this job successfully, an individual must be able to perform, with or without reasonable accommodation, each essential function satisfactorily. Reasonable accommodations may be made to help enable qualified individuals with disabilities to perform the essential functions.
- Experience in providing regulatory and quality oversight including successful submission applications to the FDA for pre-market clearance/approval/CLIA waiver and/or emergency use authorization
- Experience with companies involved with pre-market and post market compliance for devices used to aid in the diagnosis of infectious diseases
- Experience in working with interdisciplinary teams across the spectrum environmental detection, bio surveillance, and diagnostic testing.
- Experience in designing and developing study protocols for the conduct of clinical evaluations for new and improved diagnostic and screening assays to detect infectious diseases
- Expert level understanding of FDA regulation of novel products such as wearable medical devices
- Expert level understanding of design capability, design controls, design verification, device history files, Human Factors studies, reliability as determined by Fault Tree analysis/tolerance interval methods and others to achieve five-nines reliability.
Candidates for positions under contracts with the Department of Defense (DoD) may be required to pass one or more background/security investigations conducted by the DoD, U.S. Army, or other Federal Government agency.
WORKING CONDITIONS/PHYSICAL DEMANDS:
Work environment characteristics described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Laboratory/office environment; may require working evenings and weekends. While performing the duties of this job, the employee is occasionally required to stand; walk; sit; use hands to manipulate objects, tools or controls; reach with hands and arms; climb stairs; balance; stoop, kneel, crouch or crawl; talk or hear. Work may involve long periods of standing and handling of numerous chemicals and/or hazardous biological material. The employee must occasionally lift and/or move up to 25 pounds. The noise level in the work environment is usually moderate.
Masters or better in Biodmedical Science or related field.