Regulatory Affairs Manager III
Ke`aki Technologies - Fort Detrick, MD

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Ke`aki Technologies, LLC, headquartered in Honolulu, Hawaii, is a Native Hawaiian Organization (NHO) owned business. A premier government services company, Ke`aki Technologies offers a full spectrum of solutions that improve the performance and operational effectiveness of our government and Department of Defense customers. Our mission synchronized solutions are designed to deliver exactly what our customers need, when they need it. From base and range operations to biomedical defense support to telecommunications and IT services, we deliver the exact talent, tools and technologies needed to meet mission requirements.

Ke`aki Technologies has an exciting opportunity for a Regulatory Affairs Manager . The position will be located at the Omnibus Program and Engineering Technical Support Center (OPETS) located in Ft. Detrick, MD. This position requires a security clearance and a signed confidentiality agreement.

Please note: This position is contingent upon award.

DUTIES INCLUDE:
  • Assists in the organization, planning, assessment and management of regulatory affairs (FDA) and quality assurance activities to support the research, development and acquisition of JPEO-CBD medical systems. This support includes, but is not limited to:
  • o Participating on IPTs
    o Preparing, reviewing and coordinating regulatory documentation
    o Researching, troubleshooting and communicating solutions to resolve technical related to regulatory documentation
    o Ensuring that regulatory documentation is compliant and consistent within the DoD Acquisition Framework
    o Supporting development of POM recommendations and Congressional and Office of the Secretary of Defense briefings
    o Maintaining relationships with the FDA and other Federal agency personnel as necessary
    o Providing coordination and staff support for regulatory, pharmaceutical and portfolio integration chiefs.
QUALIFICATIONS / EXPERIENCE REQUIRED:
  • Successful completion of a full course of study in an accredited college or university leading to a Master’s degree in Engineering, Science, Business or a related discipline and DAU Level III certification in Program Management, Systems Planning, Research, Development and Engineering (SPRDE) or the civilian equivalent is required. A combination of a Bachelor’s degree in Engineering, Science, Business or a related discipline, DAU Level II Certification in PM or SPRDE and 8 years of experience may be substituted for a Master’s degree.
  • 8 years of general experience and 5 years of experience in a program office or similar organization.
  • Knowledge of current DoD acquisition regulations, policies and guidance.
Job Type: Full-Time

FLSA Status: Non-Exempt

Ke`aki Technologies LLC is a fast growing government service provider. Employees enjoy competitive salaries; a 401K plan with company match; medical, dental, disability, and life insurance coverage; tuition reimbursement; paid vacation and sick time; and 10 paid holidays.

For additional information on Ke`aki Technologies, LLC, please visit www.keakitech.com.

Ke`aki Technologies, LLC is proud to be an Equal Opportunity Employer/Affirmative Action Employer (EEO/AA) and applicants will be considered without regard to race, color, religion, age, sex, disability, national origin, marital status, or genetic information.

Ke`aki Technologies - 16 months ago - save job - block
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