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Outset Medical is a privately held company backed by a top-tier syndicate of investors, including Fidelity, T. Rowe Price and Warburg Pincus, pioneering the use of a new dialysis medical technology ecosystem that could profoundly change the way hemodialysis treatment is delivered. Historically, patients have had to endure little choice and control over their treatments in dialysis clinics, creating one of the least consumer-friendly sectors in medicine, and making it one of the most labor-intensive and costly for the providers who sustain it. Outset is introducing a new technology aimed at disrupting both the cost structure and patient experience of dialysis within four market segments -- dialysis clinics, hospitals, extended care facilities and home.
Responsible for managing Regulatory Affairs activity supporting both pre-market and post-market projects on an on-going basis in line with the Quality Management System and Quality Policy to ensure that the business’ products and services are fit for purpose and meet customer expectations. Responsible for product submissions, license renewals, periodic updates and registrations to regulatory agencies. You will organize regulatory information and track and control submissions, review and advise on labeling for compliance with regulatory filings, review product changes for impact on regulatory filings worldwide, and research regulatory issues and provide guidance and advice to colleagues. The incumbent for this position will support additional activities as assigned.
Essential Job Functions
Job Type: Full-time
Minimum Previous Legal Responsibility required: