Current Career Opportunity:
Regulatory Affairs Specialist
Beaufort, LLC is currently searching for a Regulatory Affairs Specialist (RAS) to serve as an IVD subject matter expert on regulatory matters and projects while assisting IVD and Diagnostics clients in developing their regulatory strategies and preparing regulatory submissions. The RAS ensures that all prepared documentation conforms to applicable regulations and standards for both domestic and international submissions. The RAS participates on regulatory project teams to consistently deliver on-time and on-budget deliverables to the client.
Requirements for the position include: a minimum of five years experience in regulatory affairs for IVD devices or Diagnostics; a Bachelor’s degree in life science or technical field, and/or equivalent work experience – experience in a consulting or CRO setting a plus; experience with FDA regulatory submission processes and procedures for IVD devices; demonstrated knowledge and experience with FDA submission requirements for Diagnostics and IVD devices, including pre-IDE meeting, 510k, PMA, PMA Supplements, and IDE; excellent oral and written communication skills; ability to successfully handle multiple responsibilities, priorities, and tasks and tight timelines, and to adapt and adjust to changing priorities; competency with basic Microsoft platform applications; Regulatory Affairs Certification required.
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