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Senior Regulatory Affairs Specialist
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Full-time
- AtriCure’s Isolator® Synergy™ Ablation System is the first medical device to receive FDA approval for the treatment of persistent Afib. AtriCure’s AtriClip® Left Atrial Appendage Exclusion System products are the most widely sold LAA management devices worldwide.
- The Senior Regulatory Affairs Specialist originates appropriate documents to obtain and maintain marketing privileges consistent with applicable government and local regulatory requirements where AtriCure conducts business.
- This position will prepare and submit submissions, which may include US device 510(k), PMA Supplements, EU, Canada, Australia, Brazilian, Japanese, and other international submissions to support business growth and continuity.
- Prepare US submissions as necessary including 510(k) regulatory applications, PMA supplements for device and manufacturing, drafting 510(k) letters to file to secure/maintain marketing approvals.
- Prepare EU, Canada, Australia, Brazilian, Japanese, and other international submissions, or notifications of change when necessary.
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