Regulatory Affairs Coordinator/Specialist

08 Oct, 2020

Jobs

Regulatory Affairs Coordinator/Specialist

Terarecon
Durham, NC

Responsibilities:

  • Review deliverables prior to inclusion in regulatory submissions. Compile, submit, and review deliverables of regulatory filings to regulatory authorities and country representatives.
  • Serve as point of contact for regulatory agency requests for additional information.
  • Identify the need for new regulatory procedures and participates in development and implementation.
  • Review process changes and determine the impact on regulatory filings, and if regulatory agency notification is required.
  • Trains stakeholders on current and new regulatory requirements to ensure organization-wide compliance.
  • Identify, monitor, and submit applicable reports (e.g., Serious Adverse Events) or notifications (e.g., changes in manufacturing) to regulatory authorities during the clinical research process.
  • Prepare and submit electronic and paper regulatory submissions according to applicable regulatory requirements and guidelines.
  • Monitor the progress of the regulatory authority review process through appropriate communication with the agency.
  • Communicate and interact with regulatory authorities before and during the development and review of a regulatory submission through appropriate communication tools.
  • Work with cross-functional teams for interactions with regulatory authorities including panel meetings and advisory committees
  • Develop, implement, and monitor processes involved with maintaining annual licenses, registrations, and listings.
  • Review and approve labeling, advertising, and promotion to ensure regulatory compliance.
  • Assure postmarket regulatory requirements are met (e.g., maintains systems to trigger reporting, provide postmarket required reports, supplemental submissions, and other postmarketing commitments.)
  • Submit notifiable changes and supplemental dossiers to the appropriate regulatory authorities to update product information and/or instructions for use to reflect the current state of product knowledge.
  • Participate in the implementation of regulatory strategy and processes for handling recalls and communication to stakeholders (e.g., Dear Healthcare Professional letters, patient letters, distributor letters, and health authorities).
  • Report product safety issues to regulatory authorities as required, to comply with local, regional, and global regulations.
  • Provide regulatory support and input and appropriate follow-up for inspections and audits

Qualifications:

  • 2-4 years in global regulatory submissions and listings for the medical device industry
  • 2-4 years in adverse event determination and reporting
  • Experience with software as a medical device or radiological software a plus
  • Experience and knowledge of product and process regulatory compliance
  • Experience with CMS and FDA parallel reviews a plus
  • Experience with FDA Digital Health Software Precertification (Pre-Cert) Program a plus

Learn more here

Job posted: 2020-10-08