Corrine
Bonfiglio, RAC
Senior Regulatory Consultant
cbonfiglio@meister.net
Corrine is a senior-level team member
with over twenty years of accomplished regulatory and clinical
affairs experience. She offers in-depth experience with regulatory
requirements, submissions and clinical trial development.
Corrine is responsible for
Compliance issues for meister.NET medical device and cell therapy related Web and multi-media
projects. Corrine has reviewed several meister.NET projects
including nexell.com, StemCellSelection.com and peregrineinc.com as
well as several biotechnology related road shows, annual meeting
presentations and press releases.
Some of Corrine's key accomplishments
include submitting a PMA to CBER and participated in preparation for
advisory panel meeting. The PMA was approved in 18 months. She was
instrumental in obtaining Canadian approval for a Class IV
combination product. Corrine also was Project Leader for conversion
of all company labeling to new corporate identity.
Corrine also has extensive experience
with regulatory strategies and submission of IDE's, 510(k)'s and
Master Files as well as import/export approvals for medical devices
and biologics. Additionally, she managed labeling (commercial and
investigational) review, approval, and production activities for
cell therapy division.
EDUCATION
- Regulatory Affairs Certified (RAC)
1994
- University of California at San
Diego BA, Biology - 1981
- Georg-August University, Göttingen,
Germany Biology/German - 1979
AWARDS
- Baxter Achievement Award for
“PL269 Cryocyte™ Product Family, Introduction and Redesign”
- Baxter Achievement Award for
“Implementation and Maintenance of an Electronic Document
Management System”
PROFESSIONAL AFFILIATIONS
Regulatory Affairs Professionals
Society (RAPS)
Orange County Regulatory Affairs Association (OCRA)
