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National Institutes of Health
, MD, United States
National Institutes of Health Regulatory Affairs Specialist Montgomery County , Maryland Apply Now Summary If you have experience managing clinical trials and providing regulatory support AND you want to play a significant role in a dynamic organization, then consider joining the Center for Cancer Research (CCR), Office of the Clinica
Job Source: National Institutes of HealthJohns Hopkins Medicine
Baltimore, MD, United States
Share This Page Job Details Requisition #: 639750 Location: Johns Hopkins Ambulatory Surgery Centers, Baltimore, MD 21201 Category: Leadership Schedule: Day Shift Job Summary The Director of Regulatory Affairs is responsible for planning, organizing, implementing and evaluating regulatory compliance initiatives to support patient safety a
Job Source: Johns Hopkins MedicineJohns Hopkins Medicine
Baltimore, MD, United States
Job Summary The Director of Regulatory Affairs is responsible for planning, organizing, implementing and evaluating regulatory compliance initiatives to support patient safety and quality and ensure continuous compliance with Federal, State and local regulatory requirements. This position concentrates on oversight of accreditation and certification
Job Source: Johns Hopkins MedicineJohns Hopkins HealthCare
Columbia, MD, United States
Job Summary The Director of Regulatory Affairs is responsible for planning, organizing, implementing and evaluating regulatory compliance initiatives to support patient safety and quality and ensure continuous compliance with Federal, State and local regulatory requirements. This position concentrates on oversight of accreditation and certificatio
Job Source: Johns Hopkins HealthCareJohns Hopkins Medicine
Columbia, MD, United States
Job Summary The Director of Regulatory Affairs is responsible for planning, organizing, implementing and evaluating regulatory compliance initiatives to support patient safety and quality and ensure continuous compliance with Federal, State and local regulatory requirements. This position concentrates on oversight of accreditation and certification
Job Source: Johns Hopkins MedicineBiomatrica
Baltimore, MD, United States
Summary of Major Responsibilities: The Regulatory Affairs Manager position is responsible for the preparation of regulatory submissions required to market in vitro diagnostic devices in both domestic and international markets. This position requires the development, execution, and management of procedures to ensure that the product development pro
Job Source: BiomatricaBiomatrica
Baltimore, MD, United States
Summary of Major Responsibilities: The Regulatory Affairs Manager position is responsible for the preparation of regulatory submissions required to market in vitro diagnostic devices in both domestic and international markets. This position requires the development, execution, and management of procedures to ensure that the product development pro
Job Source: BiomatricaCatalent Pharma Solutions
Harmans
**Regulatory Affairs Specialist** **Position Summary** Catalent Pharma Solutions is hiring a Regulatory Affairs Specialist. The Regulatory Affairs Specialist is responsible for ensuring that the company aligns with all of the regulations and laws pertaining to our business; working with federal, state, and local regulatory agencies on specific issu
Job Source: Catalent Pharma Solutions, MD, United States
If you have experience managing clinical trials and providing regulatory support AND you want to play a significant role in a dynamic organization, then consider joining the Center for Cancer Research (CCR), Office of the Clinical Director (OCD) at the National Cancer Institute (NCI)! For more information please visit: https://ccr.cancer.gov/about/office-of-the-clinical-director .
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 (https://ope.ed.gov/accreditation) 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: monitoring clinical trials to ensure applicable regulations, guidelines, and clinical practices are followed; serving as liaison and providing regulatory guidance for clinical investigators and other clinical regulatory staff; reviewing and submitting Investigational New Drug Applications (IND) and Investigational Device Exemptions (IDE) to review committees and regulatory bodies; and providing administrative and technical support to investigators involved in clinical trial research efforts.
GS-13:
In addition, to qualify for a Regulatory Affairs Specialist position at the GS-13 level, you must demonstrate at least one year of specialized experience equivalent to at least the GS-12 level in the Federal Government obtained in either the private or public sector, performing the following types of tasks: managing a portfolio of clinical trials to include protocol navigation, regulatory support and document preparation; serving as liaison and providing regulatory guidance for clinical investigators and other clinical regulatory staff; coordinating submission of protocols to scientific review panels/committees for consideration; preparing and submitting Investigational New Drug Applications (IND) and Investigational Device Exemptions (IDE) to review committees and regulatory agencies; and providing administrative and technical support to investigators involved in clinical trial research efforts.
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.
Do not copy and paste the duties, specialized experience, or occupational assessment questionnaire from this announcement into your resume as that will not be considered a demonstration of your qualifications for this position.
Preview assessment questionnaire before you apply: https://apply.usastaffing.gov/ViewQuestionnaire/12412946
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Email Alert for Regulatory Affairs Specialist jobs in , MD, United States
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