GDIT 's military health team is HIRING a Regulatory Manager to support the 59th Medical Wing (MDW), located at Lackland Air Force Base in San Antonio, Texas.
The 59th Medical Wing Science and Technology (ST) office advises and conducts clinical and translational research on matters pertaining to the medical aspects of the Air Expeditionary Force and the health of Air Force (AF) personnel and beneficiaries. In order to support the required research, ST offices conduct translational research in the areas of emergency medical care, combat casualty care, force health protection, restorative medicine, clinical and rehabilitative medicine and specialty centers.
Provides the Government with regulatory reviews, recommendations, education, training, and strategies for optimizing the transition of medical research to fielded medical products and capabilities; works closely with project teams to create and deliver regulatory strategies that enable medical products to developed, optimized, and effective while assuring compliance to regulations. May be responsible for developing, submitting, and managing product package submissions and registrations to regulatory agencies in support of clearance/approval, manufacturing, and marketing while ensuring the safety and efficacy of any drugs, foods, drugs, medical devices, and biologicals developed by the DoD.
Duties & Responsibilities:
Supports government directors, Principal Investigators (PIs), researchers, and project managers in the planning, programming, and execution of clinical research projects and protocols and associated activities to facilitate compliance and rapid achievement of regulatory clearance/approval.
Reviews proposals for product development projects to provide comments on regulatory strategies; may provide revisions to strategies or write new ones to facilitate timely approval/clearance, commercialization, and fielding.
Prepares, submits, and manages packages for regulatory review and approval; manages subsequent interactions required to address FDA requirements, questions, and requests for additional information; develops requirements for content of technical protocols, reports, and summaries used in support of the submissions.
Interprets regulatory statutes, regulations, guidance, and draft documents to assess impact to clinical research and develop solutions to avoid delays in achieving project milestone goals while ensuring compliance.
May represent organization at DoD regulatory review meetings and exchanges to assist with obtaining regulatory approval/clearances, obtain or provide guidance, and possibly develop product prioritization lists for expedited FDA reviews and emergency use authorizations.
May communicate directly with industry, government, academia counterparts to facilitate technical information exchanges, resolve issues, and optimize regulatory compliance approaches.
Provide regulatory subject matter expertise and assistance to the Institutional Review Boards (IRB), Human Research Protection Program, and other departments overseeing all aspects of human and animal research.
Maintains current knowledge of current and draft FDA and international regulations, guidance, and standards applicable to military required medical products.
Provide tailored regulatory education and training to Principal Investigators (PI), project/program managers, and new researchers.
Provide regulatory support and assistance to researchers, principal investigators, and project/program managers conducting or supporting clinical trials.
Provide regulatory subject matter expertise and assistance in reviewing and developing Instructions for Use (IFUs), human factors/engineering usability assessments, quality management systems, Risk Hazard Analyses and Management Plans, Requirements Traceability Matrixes, designs/prints for medical devices, product labels, and other aspects with establishing a Design History File (DHF) for new product development.
May be required to perform project management functions for coordinating and completing FDA and other regulatory activities.
Be knowledgeable of Defense Health Agency (DHA) and other services FDA and regulatory support operations; actively engages, interacts, and exchanges information with other regulatory experts to promote medical product development for the military.
Conducts tech scouting by reviewing reports of recently FDA approved/cleared medical products that are of interest to the DoD; May be applied to address military medical gaps/requirements, or used to enhance military medical operations; provides succinct/summarized reports to directors and operational end users/customers.
Minimum Qualification and Experience:
Master’s Degree in a medical technology management or regulatory discipline
A minimum of five (5) years of experience, preferably within the last six (6) years, of working with FDA-related regulatory reviews, package development, or regulatory process management.
Must possess a thorough knowledge of FDA processes to include applicable FDA laws, regulations, policies, procedures, scientific guidelines, and scientific information on unexpected side effects, injury, toxicity or scientific reactions associated with regulated and related products.
We are GDIT. The people supporting some of the most complex government, defense, and intelligence projects across the country. We deliver. Bringing the expertise needed to understand and advance critical missions. We transform. Shifting the ways clients invest in, integrate, and innovate technology solutions. We ensure today is safe and tomorrow is smarter. We are there. On the ground, beside our clients, in the lab, and everywhere in between. Offering the technology transformations, strategy, and mission services needed to get the job done.
GDIT is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status, or any other protected class.