Jill Wyland
Director of Quality Assurance & Regulatory Affairs @Hologic Formerly Gen-Probe
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WORK HISTORY
Director of Quality Assurance & Regulatory Affairs @Hologic Formerly Gen-Probe
Responsible for Quality Complaint and On-market regulatory submissions teams. This includes regulatory submissions associated with changes to PMA and 510(k) products such as Real-time submissions, Special 510(k), 180-day, 30-day notices, and annual reports. Responsible to ensure changes to technical files are performed in a timely manner. Other responsibilities include reporting vigilance and MDRs. Responsible to report field actions (recall and FSCA) to the appropriate regulatory agencies as well as manage all activities associated with these events.
EDUCATION
California State University, Fullerton
Masters Degree in Management Science (MS), Statistics
UC Irvine
Bachelor of Science (B.S.), Chemistry
SKILLS
ABOUT JILL WYLAND
I am a Director of Quality and Regulatory Affairs with more than twenty years of…
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