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Senior Scientist, Regulatory Affairs Specialist

Organization

MRIGlobal

Job Location

65 W. Watkins Mill Rd.
Gaithersburg, MD 20878
United States

Job Description

MRIGlobal  is looking for a Senior Scientist - Regulatory Affairs Specialist that will be responsible for working with a team from our Kansas City, MO and Gaithersburg, MD facilities to support the development of regulatory strategies for CLIA-waived, moderate to highly complex IVD submissions to US FDA ,and/or international regulatory agencies; supporting risk assessments of strategies and regulatory options to business teams and to product development/support teams; supporting regulatory product submissions, from the strategic planning stages through conduct/completion of clinical trials, and submission to regulatory agencies and post-market activities, as required.  We offer a flexible home base geographical location with periodic travel for collaboration at these two laboratory locations.

Requirements

  • Ph.D. in Biology, Microbiology, Molecular Biology, Virology, Biochemistry, Immunology or other related study area and a minimum 3 years of appropriate related experience; M.S. in Biology, Microbiology, Molecular Biology, Virology, Biochemistry, Immunology and a minimum 6 years of related experience; B.S. in Biology, Microbiology, Molecular Biology, Virology, Biochemistry, Immunology, Chemistry and minimum 9 years of related experience; or appropriate combination of education and experience
  • Minimum 3 years of directly related regulatory experience in the medical device/vitro diagnostic device or pharmaceutical area(s). Regulated experience would include supporting FDA verification or validation activities, familiarity with CLSI guidance, experience under any of the following quality standards:  ISO 13485, ISO 9001, ISO 15189, ISO 17025, CLIA, CAP etc
  • Working knowledge of medical device and/or in vitro diagnostic device regulations, 510(K) and/or Premarket Approval (PMA) process
  • Experience interpreting subjective and complex aspects of specific regulations and thorough understanding of multiple sets of associated regulations
  • Demonstrated success supporting the preparation, filing and completion of (including internal and external negotiations) regulatory submissions (Pre-EUA, EUA, 510(k), PMA, Technical Files and other regulatory documentation)
  • Experience supporting product development and product support projects, including complex projects involving ambiguity and rapid change
  • Demonstrated success understanding advanced technical/scientific principles that relate to multiple, diverse, and/or complex product lines or manufacturing processes
  • Experience analyzing complex issues and formulating cogent approaches to resolving/addressing issues
  • Demonstrated ability to exercise independent judgement and discretion within a broadly defined range of policies and practices
  • Successful history of handling multiple tasks, prioritizing activities, and scheduling work to meet business needs
  • Experience maintaining confidential information at appropriate levels within an organization
  • Ability to obtain and maintain a government security clearance, which requires United States Citizenship

How to Apply

Please apply at the link here:

https://us60.dayforcehcm.com/CandidatePortal/en-US/mriglobal/Posting/View/1387

About Our Organization

MRIGlobal, an independent research and development organization, delivers solutions in global health, national security and defense, and energy and the environment. The organization perform scientific research, advanced engineering, and program integration and management for clients in industry, government, and academia. Established in 1944 as Midwest Research Institute,  MRIGlobal is based in Kansas City, Mo., and operates in nine states and Washington, D.C.