Career Opportunities

Regulatory Affairs Manager, Cleveland,Ohio

The Cleveland VA FES Center is recognized for leadership in developing advanced techniques to restore function to individuals with paralysis and paresis. The Center's focus is on the use of Functional Electrical Stimulation (FES) systems that improve health, productivity, and quality of life for individuals with spinal cord injuries or other debilitating conditions. The Center engages in a full range of research and development activities, including conceptual design, prototype development, "in vivo" testing, clinical evaluation, and technology transfer to industry. The Center's multidisciplinary rehabilitation team is developing innovative solutions to problems that face individuals with spinal cord injury, stroke, head injury, and other paralytic conditions. FES systems to improve hand and arm function, mobility, bladder and bowel function, and respiratory function all are under evaluation. The Center's technical staff has expertise in neurophysiological systems modeling, advanced control methods, sensor development, stimulator and electrode design, implantable device packaging, and radio frequency communication. A major goal of the Center is to support the transfer of FES systems into the health care marketplace. The Center has a proven track record in this area with expertise in regulatory issues, feasibility studies, multi center clinical trials, technology licensing, and training workshops. The Center has clinical and technical facilities at several institutions including the Cleveland VA Medical Center (VAMC), MetroHealth Medical Center (MHMC), and Case Western Reserve University.

The FES Center is subject to the applicable laws and regulations enforced by the Food and Drug Administration (FDA) and the NIH Office for Protection from Research Risks (NIH OPRR). The principal regulatory activity is ensuring that the clinical studies performed by the Center are conducted with the appropriate oversight of the FDA (usually via Investigational Device Exemptions (IDEs)), as well as of local Institutional Review Boards (IRBs). FDA and IRB approvals must be obtained and maintained in order to conduct these studies. The scope of regulatory issues includes: device design, fabrication, and quality assurance; the proper conduct of non clinical studies used to support the subsequent conduct of clinical studies; and the proper design and conduct of clinical studies. The incumbent leads specific regulatory issues with the FDA and local IRBs.

Responsibilities

Regulatory Management The primary responsibilities are to provide regulatory leadership throughout the FES Center and develop a system that will address specific regulatory issues affecting the FES Center's research, development, and translation to industry of investigational neuroprosthetic devices. A cohesive regulatory documentation and monitoring system will be developed and put in place to meet regulatory guidelines. The scope of responsibility includes medical systems developed for investigational device study through systems under clinical study for feasibility studies and for premarket approval.

The incumbent will interface directly with the investigators of the FES Center and with the FDA and local IRBs as necessary.

The principal activity is the overall development of a cohesive regulatory framework and reporting system. This includes the preparation and submission of documents to the FDA and to local IRBs. The incumbent is responsible for the regulatory documentation associated with specific research projects, as assigned by the FES Center Director. The incumbent will collect, assemble, collate, interpret, and document all pertinent information needed for specific regulatory submissions. In addition, the position entails the following related activities: ensuring that device design, manufacture, testing, deployment and evaluation are properly documented for regulatory reporting needs; helping to plan, coordinate, and monitor clinical investigations of new devices; ensuring that research with human subjects is tracked, and that informed consent is obtained and documented; periodically preparing supporting documents for submission to the FDA and IRBs; and interfacing directly with the FDA and IRBs when necessary.

Clinical Studies Support: The incumbent provides leadership and direction for the Clinical Advisory Board which regulates clinical studies center-wide and device deployment and evaluation in specific clinical studies. This includes developing systems for planning, coordinating, and monitoring such studies to ensure data for regulatory reporting needs is obtained.

Non Clinical Studies Support: The incumbent provides direction for device deployment and evaluation in studies involving laboratory animals. This includes developing systems for planning, coordinating, and monitoring such studies to ensure data for regulatory reporting needs is obtained.

Supervisory Responsibility: The incumbent will supervise and provide direction for the regulatory affairs specialist position. This entails working with the regulatory affairs specialist to develop the infrastructure to initiate a consistent center-wide monitoring process.

Position Location: This position will have a primary office at the Cleveland FES Center and swing office space at MetroHealth Medical Center, Cleveland Louis Stokes VA Hospital and The Technology Design Laboratory (TDL).

Contact:
Cheryl Dudek
11000 Cedar Avenue, Suite 230
Cleveland, Ohio 44106

Phone: (216) 231-3257
Fax: (216) 231-3258

Research Position, Cleveland,Ohio

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The Cleveland Functional Electrical Stimulation (FES) Center, a Department of Veterans Affairs Rehabilitation Research and Development National Center of Excellence, is seeking a new investigator to develop independent research programs in neural prostheses to restore upper extremity function following stroke. Present investigations within the center focus on neural prostheses for restoration of both upper and lower extremity function, swallowing, bladder function, and respiratory function. The center has a wide range of interdisciplinary studies ranging from basic discovery and the development of next generation technology, to system design, clinical implementation and assessment. There are a growing number of physicians, engineers, and scientists within the FES Center and the Cleveland area that are actively investigating rehabilitation devices and therapies. We are looking to add another dynamic young investigator to the upper extremity stroke program to solidify and expand its presence within Cleveland.

Requirements

Applicants are expected to have a Ph.D. in biomedical engineering or other closely related discipline at time of hire and show a significant potential for developing independent funding. Post-doctoral experience is desirable, but not required. The successful applicant will work with investigators of the FES Center to develop neuroprosthetic systems for implementation in upper extremity stroke. The position provides full salary support for up to two years. The investigator will be expected to generate peer review publications and applications for research funding within 12 months. Only US citizens are eligible. Salary is competitive and commensurate with experience.