Jill Wyland

Director of Quality Assurance & Regulatory Affairs @Hologic Formerly Gen-Probe

San Diego, CA, US
EMAILS
j••••••••@hologic.com
MOBILE NUMBERS
+17•••••••18

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WORK HISTORY

Oct 2016 — Present

Director of Quality Assurance & Regulatory Affairs @Hologic Formerly Gen-Probe

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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

1992 — 1996

California State University, Fullerton

Masters Degree in Management Science (MS), Statistics

1980 — 1985

UC Irvine

Bachelor of Science (B.S.), Chemistry

SKILLS

Iso 14971Communication SkillsClinical TrialsProductivity ImprovementComputer System ValidationBest PracticesGcpTroubleshootingLifesciencesTechnical ManagementInjectableQuality EngineeringProject ManagementSurveillanceInternal AuditProcess QualificationFdaDeviation ManagementIncident InvestigationCommercializationValidationLimsProcess ImprovementQuality ManagementCapaMedical Devices21 CfrCorporate CommunicationsFda GmpRegulatory AffairsQuality ControlSystems Trouble ShootingIso 13485Supplier QualityRoot Cause AnalysisImmunoassaysLean ManufacturingQuality AssuranceGxpGmp

ABOUT JILL WYLAND

I am a Director of Quality and Regulatory Affairs with more than twenty years of…

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