Senior Regulatory Affairs Specialist
Yesterday
Description
• Ensure Proscia’s diagnostic imaging products meet regulatory requirements • Manage global device registrations and authorizations • Prepare and maintain domestic and international regulatory filings • Determine market authorization requirements in assigned geographies • Provide input on regulatory requirements to product development • Guide product development teams on applicable regulations • Maintain compliance checklists • Assess regulatory impact of device design changes • Support product safety evaluation and reporting • Interface with regulatory agencies as needed
Requirements
• Authorization to work in the U.S. • BS degree in a relevant field • BS in Engineering or Science preferred • 5+ years of medical device experience • SaMD experience preferred • Ability to identify and apply medical device regulations, standards, and regulatory guidance • Experience with SaMD, diagnostic imaging, pathology, companion diagnostics, digital biomarkers, molecular diagnostics preferred • Experience managing or leading regulatory submissions (e.g. FDA 510(k) and EU IVDR technical documentation) and/or international registrations
Benefits
• competitive pay • supported with savings options • insurance options that promote long-term health and personal growth • free food • gourmet coffee • craft beer • wellness rooms
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