Current Career Opportunity:
Regulatory Affairs Manager - IVD
Beaufort, LLC is currently searching for a Regulatory Affairs Manager, IVD (RAM-IVD) to serve as the frontline client liaison for assigned regulatory assignments and projects. The RAM-IVD works with IVD and Diagnostics clients as a subject matter expert to assess their regulatory needs, identify objectives, and define project requirements. The RAM-IVD leads and manages regulatory project teams to consistently deliver on-time and on-budget deliverables to the client. The RAM-IVD prepares required documentation for both domestic and international submissions. The RAM-IVD identifies potential challenges and develops and/or recommends appropriate solutions. The RAM-IVD provides training on regulatory affairs processes and methods.
Requirements for the position include: a minimum of 10 years experience in regulatory affairs for IVD devices or Diagnostics; a minimum of five years managing the processes and individuals responsible for assuring the integrity of IVD devices or Diagnostics regulatory affairs systems; a Bachelor’s degree in life science or technical field, and/or equivalent work experience (Master’s preferred) – experience in a consulting or CRO setting a plus; experience with FDA regulatory submission processes and procedures for IVD devices or Diagnostics; demonstrated knowledge of IVD device or Diagnostics submission requirements, including pre-IDE meeting, 510k, PMA, PMA Supplements, and IDE; experience in writing analytical and clinical validation study protocols for diagnostics per FDA regulations and CLSI guidelines; 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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