Principal Regulatory Affairs Specialist

VirtualVocations
Portland, Oregon, United States
Full-time

A company is looking for a Principal Regulatory Affairs Specialist, US Regulatory Policy.Key ResponsibilitiesDevelop and execute U.

S. regulatory advocacy strategies and action plansMonitor and analyze U.S. regulatory guidelines, regulations, and policies related to medical devicesLead the preparation of document packages for regulatory submissions and recommend changes for complianceRequired QualificationsBachelor's degree plus 7+ years of related experience in the medical device industry or a regulatory agency (or 5+ years with an advanced degree)Demonstrable understanding of U.

S. FDA regulatory requirements and policyRegulatory experience within the medical device industry or a regulatory agencyExperience in advocacy related to healthcare policy and regulationsStrong research and analytical skills with a global mindset

20 days ago
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