| Job Description | Battelle is guided by a founding mission. We invest our knowledge, talents and resources, helping our customers achieve their most important goals. We apply scientific rigor and creativity, succeeding where others may fail and we invest in our communities, making the world better for generations to come. All of us share a common purpose: to solve the greatest challenges of today and tomorrow.
Our 22,000 employees work at the forefront of scientific innovation to tackle critical challenges in security, human health, manufacturing, energy and environmental management. Battelle’s work is grounded in the belief that science, technology and a passion for excellence can make industries more competitive and the world a better place.
Battelle’s Technical On-site Professional Services (TOPS) provides support to programs and activities within the Centers for Disease Control and Prevention (CDC) in Atlanta, Georgia. Our mission is to provide high-quality technical support to CDC and its’ partners through technical staffing, program management, and reach-back capabilities through our advanced laboratory operations in Columbus, Ohio and other locations.
CDC has a critical role in preparing for and responding to infectious disease emergencies. Appropriate use of Public Health Emergency Countermeasures (PHEMC) relies on CDC and public health partners’ capability to rapidly and accurately detect biothreats and to quickly provide prevention and treatment interventions. Several recent public health responses have identified challenges to rapid availability of diagnostics and preventive measures.
Our TOPS Group is currently seeking an In Vitro Diagnostics – Scientist/Regulatory Specialist. This position operates within a multifunctional team that facilitates the advanced development of several in vitro diagnostic products designed to detect and characterize influenza virus or other respiratory pathogens. This position located in Atlanta, GA. Limited relocation support is available for this position.
RESPONSIBILITIES:
Coordinate, prepare input, and assemble submission packages (e.g. FDA premarket 510(k), or PMA) in coordination with the CDC Regulatory Affairs Office.
Work in conjunction with the CDC Regulatory Affairs Office, Battelle Program Managers, and Battelle Product Manager to develop regulatory strategies and written plans for several in vitro diagnostic products.
Coordinate agendas for meetings between the CDC and FDA on in vitro diagnostic products in development at CDC.
Assist in the decision-making process for determining reportable complaints per FDA regulations for medical device reporting (MDR).
Contribute to risk assessments and development of mitigation strategies for in vitro diagnostic products being considered for FDA submission or currently in production.
Author regulatory documents incorporating input from product development, manufacturing, and regulatory perspectives associated with in vitro diagnostic product development. Coordinate review and finalization of documentation.
Give oral presentations of project progress and coordinate meetings to obtain technical expert input.
THE FOLLOWING REQUIREMENTS MUST BE MET IN ORDER TO BE CONSIDERED FOR THIS POSITION:
A scientific background is absolutely required for the successful performance of duties in this position. There are no laboratory responsibilities, however prior laboratory training and experience is necessary to carry out the functions of the position.
A minimum of a Master’s degree in a biological science and direct experience with molecular testing technologies (e.g. real-time PCR or DNA sequencing).
Minimum of 2 years’ experience working in the area of in vitro diagnostic development including assay validation responsibilities (analytical and clinical evaluation of assay performance).
Experience with the application and implementation of the FDA Quality System Regulation.
Excellent written and oral communication skills. A strong proficiency in writing documents of a technical nature is required as well as working familiarity with standard word processing and presentation software (i.e. MS Office products).
THE FOLLOWING IS DESIRED, BUT NOT REQUIRED TO BE CONSIDERED FOR THIS POSITION:
Direct experience with producing data or information contributing to regulatory submissions involving in vitro diagnostic devices employing real-time polymerase chain reaction (PCR) technology.
Experience working with government contracts and subcontractors.
Practical experience in communications with regulatory agencies.
Applicants with demonstrated experience working on FDA and/or CE cleared device submissions will be preferentially considered. |
| | Company | | Battelle | Job Code | | State or Province | | Georgia | | |
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