Regulatory Affairs Coordinator/Specialist
- 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
- 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
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Job posted: 2020-10-08