AdvaMed 510(k) Submissions Workshop Attendees
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This document lists the attendees of the AdvaMed 510(k) Submissions Workshop held in Washington, D.C. on October 15-16, 2018. It includes over 80 names, job titles, and companies of individuals in regulatory affairs, quality assurance, engineering, and legal roles from medical device and diagnostic companies, as well as representatives from the FDA and industry associations.
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AdvaMed 510(k) Submissions Workshop Attendees
- 1. 1 AdvaMed 510(k) Submissions Workshop Grand Hyatt Washington Washington, DC Oct. 15-16, 2018 List of Attendees Dylan Alu Badge Name: Dylan Regulatory Affairs Specialist Neuronetics Malvern, PA Betsy Anda-Harris Badge Name: Betsy Team Leader Ortho Clinical Diagnostics, Inc. Raritan, NJ Raul Arevalo Badge Name: Raul Sr. Regulatory Affairs Specialist Medtronic Neurosurgery Goleta, CA Noelle Bagnall Badge Name: Noelle Vice President, Business Development eLum Technologies, Inc Fremont, CA Pragnya Bakka Badge Name: Pragnya Regulatory Affairs Specialist Zimmer Trabecular Metal Technology Parsippany, NJ Ganesh Balachandar Badge Name: Ganesh Regulatory Affairs Specialist Microvention Inc. Aliso Viejo, CA Jennifer Bennett Badge Name: Jen Sr. Analyst, Regulatory Affairs Beckman Coulter, Inc. Chaska, MN Medha Bharadwaj Badge Name: Medha Regulatory Affairs Specialist FUJIFILM SonoSite, Inc. Bothell, WA Cindi Brooks Badge Name: Cindi Manager, Meetings & Conferences Advanced Medical Technology Association Washington, DC Nicolette Cannella Badge Name: Nicki Specialist, Regulatory Affairs Abbott Fort Worth, TX Kimberly Carden Badge Name: Kim Rotation Associate Integra LifeSciences Corporation Plainsboro, NJ Aditi Chaubal Badge Name: Aditi Regulatory Affairs Specialist FUJIFILM SonoSite, Inc. Bothell, WA
- 2. 2 Lindsay Clayboss Badge Name: Lindsay Regulatory Associate I Medcomp Harleysville, PA Tammy Dean Badge Name: Tammy Regulatory Affairs Elecsys Manager Roche Diagnostics Operations, Inc. Indianapolis, IN Angela Demarco Badge Name: Angela Biomedical Engineer U.S. Food and Drug Administration Silver Spring, MD Mary Dockery Badge Name: Mary Regulatory Affairs Specialist BIOTRONIK, Inc. Lake Oswego, OR Benjamin Dollins Badge Name: Ben Regulatory Affairs Specialist Boston Scientific Corporation Saint Paul, MN Sean Fallon Badge Name: Sean Rotational Associate Integra LifeSciences Corporation Plainsboro, NJ Teri Feeley Badge Name: Teri Regulatory Specialist Acelity San Antonio, TX Kate Fink Badge Name: Kate Project Manager Martech Medical Products, Inc. Harleysville, PA Elizabeth Garza Badge Name: Liz Regulatory Affairs Specialist II Acelity San Antonio, TX Clayton Ginn Badge Name: Clayton Regulatory Technical Specialist Siemens Healthcare, Molecular Imaging Knoxville, TN Seiko Hamada Badge Name: Seiko Olympus Corporation Tokyo, Japan John Hao Badge Name: John Rotation Associate Integra LifeSciences Corporation Plainsboro, NJ Joshua Hubbard Badge Name: Josh Sr. Project Engineer Manager RK Manufacturing Corporation Danbury, CT Danielle Humphrey Badge Name: Danielle Counsel Hogan Lovells US LLP Washington, DC Nathaniel Ivey Badge Name: Nathan Regulatory Health Project Manager U.S. Food and Drug Administration Silver Spring, MD Rachel Johnson Badge Name: Rachel Marketing Manager Advanced Medical Technology Association Washington, DC
- 3. 3 Angela Johnson Badge Name: Angie Regulatory Affairs Specialist II ACIST Medical Systems Eden Prairie, MN Sammie Joseph-Fredericks Badge Name: Sammie Sr. Regulatory Affairs Specialist Medtronic Mounds View, MN Marium Khalid Badge Name: Marium Rotational Associate Integra LifeSciences Corporation Plainsboro, NJ Zarnain Khan Badge Name: Zarnain Regulatory Submissions Specialist Varian Medical Systems, Inc. Palo Alto, CA Jisun Kim Badge Name: Ji Quality, Regulatory, and Operations Rotation Associate Integra LifeSciences Corporation Plainsboro, NJ Courtney Kleist Badge Name: Courtney Regulatory Affairs Specialist Abbott St. Paul, MN Amy LaBarre Badge Name: Amy Director of Quality RK Manufacturing Corporation Danbury, CT Tran Le Badge Name: Tran Quality, Regulatory Affairs, and Global Operations Rotational Associate Integra LifeSciences Corporation Plainsboro, NJ Jonathan Lee Badge Name: Jonathan Regulatory Affairs Specialist Freudenberg Medical Carpinteria, CA Jonathan Lendrum Badge Name: Jonathan Regulatory Affairs Consultant Fang Consulting, Ltd. Minneapolis, MN Cecilia Lopez Badge Name: Cecilia Manager, Marketing - Conferences & Events Advanced Medical Technology Association Arlington, VA Michael Lorenz Badge Name: Michael Senior Analyst, Regulatory Affairs Beckman Coulter, Inc. Chaska, MN Nicole Lyden Badge Name: Nicole Sr. Regulatory Affairs Specialist Boston Scientific Corporation Saint Paul, MN Mia McCorkel Badge Name: Mia Regulatory Affairs Specialist Stryker Sustainability Solutions Tempe, AZ Nan McIntosh Badge Name: Nan Regulatory Affairs Specialist FUJIFILM SonoSite, Inc. Bothell, WA Catherine McNally Badge Name: Catherine Senior Regulatory Affairs Specialist Stryker Instruments Portage, MI
- 4. 4 Kelsey Moser Badge Name: Kelsey Regulatory Affairs Associate Arthrex Inc. Naples, FL Walter Murray Badge Name: Walt Strategic Partner MasterControl Inc. Salt Lake City, UT Anita Nemeth Badge Name: Anita Sr. RA Analyst B. Braun Medical Inc. Allentown, PA Yen Nguyen Badge Name: Yen Principal Regulatory Affairs Specialist Cepheid Sunnyvale, CA Diana Osgood Badge Name: Diana Sr. Regulatory Affairs Specialist Medcomp Harleysville, PA Jackie Perri Badge Name: Jackie RA Specialist Stryker Corporation Mahwah, NJ MARY PRUNTY Badge Name: Mary Regulatory Affairs Manager VISTAMED LTD CARRICK ON SHANNON, Ireland Shahla Riazi Badge Name: Shahla Consumer Safety Officer U.S. Food and Drug Administration Silver Spring, MD Rita Ricker Badge Name: Lauren Regulatory Affairs Specialist Zimmer Biomet Warsaw, IN Ekaterina Shanina Badge Name: Ekaterina Regulatory Affairs Specialist Varian Medical Systems Oncology Division Palo Alto, CA Patricia Shrader Badge Name: Pat Senior Counsel Hogan Lovells US LLP Washington, DC Jody Stoughtenger Badge Name: Jody Sr. Specialist, Regulatory Affairs Fresenius Kabi USA, LLC Lake Zurich, IL Bryant Tate Badge Name: Bryant Senior Regulatory Affairs Professional Abbott Diagnostics Irving, TX Ifeanyi Uwemedimo Badge Name: Ifeanyi Biomedical Engineer U.S. Food and Drug Administration Silver Spring, MD Micaela Victoria Badge Name: Micaela Regulatory Affairs Specialist II Penumbra, Inc. Hayward, CA Amit Vora Badge Name: Amit Integra LifeSciences Corporation Plainsboro, NJ
- 5. 5 Rong Wang Badge Name: Joyce QARA VP, Medtronic Greater China Medtronic China Shanghai, China Jauna Werner Badge Name: Jauna VP-Supply Chain and Quality Securisyn Medical Highlands Ranch, CO