Regulatory Health Consultant, Mid

Key Role:

Apply problem-solving expertise in health or life science to develop solutions to operational and strategic challenges for federal public health agencies. Work with project delivery teams to provide analytical support for the execution of project approaches, the development of deliverables, and strategic recommendations to drive organizational improvements in business processes, program operations, strategic planning, policy effectiveness, and decision making. Conduct methods of quantitative and qualitative data collection and analyses to derive insights on client issues, evaluate trends, and assess potential solutions. Support the communication of practical solutions to clients in the form of data-driven presentations, briefings, and reports.

Basic Qualifications:

-3+ years of experience in a professional work environment

-Knowledge of medical product development and regulatory pathways

-Ability to work in a team-based or project environment

-Ability to obtain a security clearance

-BA or BS degree

Additional Qualifications:

-1+ years of experience in working with the FDA

-1+ years of experience with the health or medical product industries, including R&D, clinical, regulatory, marketing, strategy, operations, manufacturing, or consulting

-1+ years of experience with strategy or management consulting

-Experience with business process modeling

-Knowledge of medical product development and regulatory pathways

-Ability to lead projects or tasks

-Possession of excellent analytical skills

-Possession of excellent oral and written communication skills

-MA or MS degree in a life science, engineering, or health-related field preferred; MBA or PhD degree in a life science, engineering, or health-related field a plus

-Regulatory Affairs Certification (RAC)

Clearance:

Applicants selected will be subject to a security investigation and may need to meet eligibility requirements for access to classified information.

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