Regulatory Affairs Specialist

This position is located within the Clinical Trials Unit of the Office of the Clinical Director (OCD), The National Institute of Neurological Disorders and Stroke (NINDS), National Institutes of Health (NIH).
Basic Qualifications In order to qualify for a Regulatory Affairs Specialist, GS-0601, position you must have successfully completed a Bachelor's degree or graduate/higher level degree with major study in an academic field related to the medical field, health sciences or allied sciences appropriate to the work of the position. (This degree must be from an educational program from an accrediting body recognized by the U.S. Department of Education at the time the degree was obtained).
Additional Qualifications GS-12 In addition, to qualify for a Regulatory Affairs Specialist position at the GS-12 level, you must demonstrate at least one year of specialized experience equivalent to at least the GS-11 level in the Federal Government obtained in either the private or public sector, performing the following types of tasks:
Providing regulatory guidance, review, and assistance to clinical investigators and other clinical regulatory staff;
Reviewing clinical protocols for regulatory compliance and internal consistency;
Ensuring Investigational New Drug (IND) and Investigational Device Exemption (IDE) products are in compliance with regulations and industry best practices;
Supporting maintenance of safety trackers and databases;
Providing professional and technical assistance to staff and research study teams.
You will receive credit for all experience material to the position, including experience gained in religious, civic, welfare, service, and organizational activities, regardless of whether you received pay.
Preview assessment questionnaire before you apply: https://apply.usastaffing.gov/ViewQuestionnaire/********

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