
Simona Bancos
- Association for the Advancement of Medical Instrumentation (AAMI) Group Award. - FDA Alternate Liaison and FDA Biocompatibility Technical... | Silver Spring, Maryland, United States
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Simona Bancos’s Emails si****@fd****.gov
Simona Bancos’s Phone Numbers 1301796****
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Simona Bancos’s Location Silver Spring, Maryland, United States
Simona Bancos’s Expertise - Association for the Advancement of Medical Instrumentation (AAMI) Group Award. - FDA Alternate Liaison and FDA Biocompatibility Technical Expert at International Standard Organization (ISO) Technical Committee (TC) 172 Optics and Photonics, Sub-committee (SC) 7 Ophthalmic Optics and Instruments, Working Group (WG) 7 Ophthalmic Implants. - FDA Primary Liaison at American Society for Testing and Materials (ASTM) Subcommittee F04.16, Biocompatibility Test Methods. - FDA Alternate Liaison at AAMI/WG5- ISO/ TC 194/WG 5, Cytotoxicity. - CDRH Alternate Representative at the Interagency Coordinating Committee on the Validation of Alternative Methods (ICCVAM). - CDRH Alternate Representative at US Pharmacopeia (USP). - Recipient of numerous Agency Awards. - Extensive regulatory expertise in reviewing pre-market applications (510(k), IDE, First-in-Human Early Feasibility Studies, PMAs, de novo) for a wide variety of ophthalmic devices (intraocular pressure lowering devices for glaucoma, intraocular lenses, ophthalmic viscoelastic devices, etc.). - Lead complex PMA submissions for first-of-a kind devices. - Recognized as an authority on biocompatibility testing for ophthalmic devices. - Authored FDA guidance documents. - FDA technical expert for biocompatibility testing of intraocular lenses. - Represented FDA at international scientific meetings and presented the regulatory review processes for medical devices. - Acted as Branch Chief. - Extensive experience in Immuno- and Nano-toxicology, Molecular and Cellular Biology.
Simona Bancos’s Current Industry Us Food And Drug Administration
Simona
Bancos’s Prior Industry
Hungarian Academy Of Sciences
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University Of Rochester Medical Center
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Food And Drug Administration Center For Drug Evaluation And Research
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Us Food And Drug Administration
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Work Experience

Us Food And Drug Administration
Toxicology and Team Lead Reviewer
Sat Jun 01 2013 00:00:00 GMT+0000 (Coordinated Universal Time) — Present
Food And Drug Administration Center For Drug Evaluation And Research
ORISE Fellow
Sat Jan 01 2011 00:00:00 GMT+0000 (Coordinated Universal Time) — Sat Jun 01 2013 00:00:00 GMT+0000 (Coordinated Universal Time)
University Of Rochester Medical Center
Postdoctoral fellow
Wed Oct 01 2003 00:00:00 GMT+0000 (Coordinated Universal Time) — Tue Feb 01 2011 00:00:00 GMT+0000 (Coordinated Universal Time)
Hungarian Academy Of Sciences
Ph.D
Fri Sep 01 2000 00:00:00 GMT+0000 (Coordinated Universal Time) — Tue Jul 01 2003 00:00:00 GMT+0000 (Coordinated Universal Time)