Keegan Bate

About Keegan Bate

I am originally from Maine and am currently living in Salt Lake City working as a…

Experience

1. Regulatory Affairs Associate

   Biofire Diagnostics, Llc

   Apr 2018 — Present · Salt Lake City, UT, US

   Principal Duties:• Prepare and submit US regulatory submissions [Pre-submissions, 510(k)s, direct de novo applications, etc.]• Prepare and maintain product technical files for CE marking• Analyze and understand regulatory requirements and provide direction for proper implementation of said requirements• Organize and prepare documents for international submissions. Coordinate with international counterparts to obtain product approvals and renewals• Prepare plans, procedures, and regulatory documents for new products or regulatory submission processes• Support review of labeling and marketing materials• Maintain current knowledge of existing and emerging regulations, standards, and guidelines• Interpret regulatory rules, assess rule changes, and ensure their proper communication through corporate policies and procedures• Review and assess product change impacts (device/labeling) for US and international markets and generate regulatory notification plans

Education

• University of Maine

  Bachelor of Engineering - BE, Bioengineering

  2011 — 2015

• University of Southern California

  Master's degree, Biomedical Engineering

  2016 — 2017

• Regulatory Affairs Professionals Society

  Regulatory Affairs Certificate: Medical Devices

  2018 — 2018

Skills

• 510(K)
• Microsoft Office
• Nanotechnology
• Research
• Imagej
• Corrective and Preventive Action (Capa)
• Mathcad
• Microsoft Excel
• Powerpoint
• Ni Labview
• Solid Edge
• Python
• Minitab
• Regulatory Documentation
• Github
• Social Media
• Regulatory Submissions
• Uv/Vis Spectroscopy
• Dynamic Light Scattering
• Matlab