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Interact and negotiate with regulatory agencies / Notified Bodies to support product life cycle management, including FDA for Class II and III Pre-Submission Meetings and PMA submissions, Health Canada for Class III/IV submissions, and EU MDR Class I - IV submissions and change notifications.
ExpandApply NowActive JobUpdated 11 days ago - UpvoteDownvoteShare Job
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Coordinate, compile, and submit US and EU regulatory filings for new and modified products, including PMA Supplements, pre-submissions, 510(k)s, Annual Reports, and CE Mark submissions under MDR.
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Preferred Qualifications 4+ years of related regulatory submission experience from medical device, pharmaceutical, or healthcare industryAdvanced level degreeClass II or Class III medical device experienceExperience with PMA supplements, 510(k) applications, and US device regulations and/or experience with EU and other international medical device regulations and submissions.
$72,700 - $145,300 a yearFull-timeExpandApply NowActive JobUpdated 5 days ago - UpvoteDownvoteShare Job
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Experience with PMA supplements, 510(k) applications, and US device regulations and/or experience with EU and other international medical device regulations and submissions. Abbott is seeking a passionate, experienced Senior Regulatory Affairs Specialist to join our team on-site in Plymouth, or St. Paul, MN. In this role, you will lead the preparation and submission for regulatory approvals and identify and resolve problems.
Full-timeExpandApply NowActive JobUpdated 5 days ago
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