B.S., Biomedical Engineering @
Rensselaer Polytechnic Institute
Graduated RPI with a B.S. in Biomedical Engineering and Franklin Pierce Law Center, now known as UNH School of Law, with a Masters in Intellectual Property. Previously worked on HIV Vaccine Patent Research and as a Patent Agent at DEKA R&D. Currently using the skills and knowledge gained from past education and experiences towards a career path
Graduated RPI with a B.S. in Biomedical Engineering and Franklin Pierce Law Center, now known as UNH School of Law, with a Masters in Intellectual Property. Previously worked on HIV Vaccine Patent Research and as a Patent Agent at DEKA R&D. Currently using the skills and knowledge gained from past education and experiences towards a career path in the medical device industry as a Regulatory Affairs Specialist.
Regulatory Affairs Specalist @ Manage various FDA Class I, II (510(k) cleared and exempt), and III (PMA required) product lines
Manage EU Class I, I sterile, and IIa product lines along with associated Technical Files
Handle International product licensing and registration in countries including Japan, Australia, Canada, Brazil, Taiwan, China, and Korea
Provide Regulatory guidance for new product development in team setting for domestic and international sales
Provide Regulatory guidance for design changes and requirements for both domestic and foreign requirements
Monitor International Standards and update company list of applicable standards
Ensuring company-wide Regulatory compliance with the FDA UDI (Unique Device Identifier) requirement for Class III devices and assisting with Class II devices
Assist with Special and Traditional 510(k) submissions to the FDA
Review and approve labeling and marketing material
Create Technical File for new products From June 2013 to Present (2 years 7 months) Utica, New York AreaOffice Manager @ Research and deploy innovative business advancements in technology, including software and hardware optimizing personnel performance and presenting them to executives.
Manage, improve, provide guidance, and problem solve business and budget issues, assignments, and project components.
Ensure obligations of company and employees are met and adhere to requirements.
Use Quickbooks Pro to manage the bookkeeping and management of the office.
Handle Human Resources obligations to the employees. From January 2010 to May 2013 (3 years 5 months) Greater New York City AreaCo-Author of Publication @ K.Clark, J.Cavicchi, K.Jensen, R.Fitzgerald, A.Bennet, and S.P.Kowalski. "Patent data mining: A tool for accelerating HIV vaccine innovation." Vaccine. 29. 24(2011): 4086-4093 From June 2009 to May 2011 (2 years) Work Study @ HIV Vaccine Technologies Patent Landscape Project
Provided support in cataloging, organizing, and analyzing large corpus of patent documents.
Separated claims portion of patent documents for use in HIV Vaccine research.
Searched and located relevant patent documents for HIV Vaccine research
Created Aureka Themescape maps based upon patent documents from HIV Vaccine research and Biofuel research.
Coauthored and reviewed article listed above, published in “Vaccine.” From August 2008 to May 2011 (2 years 10 months) Legal Extern @ Studied known prior art preceding meeting with engineers for invention disclosure meetings.
Organized and hosted invention disclosure meetings with engineers working on the subject of patent applications.
Drafted patent applications, including meeting with draftsman to determine necessary drawings and e-file applications submissions to USPTO.
Independently wrote legal memos, prepared & e-filed IDS, organized patent portfolios, & performed trademark search. From June 2009 to August 2009 (3 months)
Masters, Intellectual Property Law @ Franklin Pierce Law Center From 2008 to 2010 B.S., Biomedical Engineering @ Rensselaer Polytechnic Institute From 2004 to 2008 Rachelle RAC is skilled in: Patents, Intellectual Property, Biotechnology, Medical Devices, Biomedical Engineering, R&D, Regulatory Affairs, Legal Writing, Research, Westlaw, Due Diligence, Microsoft Office, Patentability, Vaccines, Legal Research
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