A
Anders K.
Italia
ANDERS KISS
anderskiss11@gmail.com
github.com/Anderche
+39 348 269 8213
+36 70 278 4217
SKILLS, SOFTWARE, & INTERESTS
• Ruby on Rails • Git • Medical Technology • Data Visualization • Python • JavaScript • React • D3.js • Solidity • Blockchain (MetaMask) •Bootstrap • Authentication & Authorization • Geocoding (MapBox & Google APIs) • Adobe CS • Sketch • Figma • InVision
EDUCATION
Le Wagon | Fullstack Ruby on Rails Developer Bootcamp | Milan, Italy | 01.2019 – 03.2019
• 9-week bootcamp focused on Ruby on Rails web development
• Skills: RoR, HTML, CSS, JavaScript, Front-End (Bootstrap), Git, DOM, AJAX, OOP, Advanced Routing, ActiveRecord, Hosting & Image Upload (Cloudinary), Authentication & Devise, Authorization & Pundit, Geocoding (MapBox, Google API’s), Search (Algolia), Payment (Stripe), Mailing, Background Jobs (Redis/Sidekiq), API, Test Driven Development (TDD), webpack.
• Projects: Social movie picker; a mobile-first web app for friends to discover shared movie interests to help plan group movie nights && Instrument rental marketplace (similar to the AirBnb user-journey)
M.Sc., Biomedical Technology Development & Management | Georgetown Univ. | Washington, DC, U.S. | 09.2009 - 05.2011
B.Sc., Biological Sciences | Virginia Tech | Blacksburg, VA, U.S. | 09.2005 - 05.2009
EXPERIENCE
Validant Consulting | Consultant, Medical Device Regulation | San Francisco, CA , U.S. | 09.2018 – 12.2018
• Updated product licenses to maintain European sales • Managed product documentation updates with client Engineering,
Marketing, & Clinical teams to meet European Directives (MDR 2.7/1 Rev. 4) • Completed the ‘General Safety and Performance
Requirements’ (GSPR) checklists assessing all aspects of the medical product design, clinical aspects, and post-market
surveillance • Performed Gap Analyses on the client design documentation • Tracked documentation in client Quality
Management system for SME tracking.
Johnson & Johnson | Regulatory Affairs Consultant | Irvine, CA, U.S. | 02.2017 – 09.2018
• Managed 30x registrations for Europe, China, Japan, Russia, and Brazil for all product lines • Revised European Technical
Files for Sterilizers and Disinfection capital equipment • Led calls with international affiliates to review registration updates and
timelines • Worked with SME’s (Engineering, Marketing, Supplier Quality, etc.) to meet various registration timelines
ZAETAE, Inc. | Founder & CEO | Boston, MA, U.S. | 10.2015 – 01.2017
• Awarded $30,000 grant from Startup Chile (Generation 15); www.startupchile.org • Managed the development of a multisided
platform connecting patients and providers worldwide - we helped patients find affordable medical treatment.
Implemented regulations for HIPAA and Personal Health Information (PHI) compliance • Hired remote team for development,
and legal incorporation
PENTAX Medical | Senior Regulatory Affairs Specialist | Montvale, NJ, U.S. | 03.2014 – 10.2015
• Licensed 50x international product licenses for endoscopes, colonoscopes, video processors and ENT devices • Performed
gap analysis of European CE-Mark compliance (e.g. Restriction of Hazardous Substances) and advised team on remediation •
Completed Regulatory Assessments to start design on a HIPAA / DICOM compliant software • Revised procedures (Design
Controls and Identification of New Standards) • Contributed to successful FDA Inspections & TÜV audit.
Ellman, International | Regulatory Affairs Associate | Hicksville, NY, U.S. | 02.2012 – 03.2014
• Contributed to four 510(k) submissions: a software update to an existing radiofrequency (RF) generator, an expanded indication (for wrinkle reduction among darker skin phototypes), a cellulite-reduction massage handpiece, and a laser lens intended for hair removal • Registered Radiofrequency surgical generators & aesthetic lasers in China, Europe, Korea, Japan, Canada, Israel, and Thailand • Prepared for FDA Inspections and TUV audits. Managed a recall (international and US) with the FDA.
anderskiss11@gmail.com
github.com/Anderche
+39 348 269 8213
+36 70 278 4217
SKILLS, SOFTWARE, & INTERESTS
• Ruby on Rails • Git • Medical Technology • Data Visualization • Python • JavaScript • React • D3.js • Solidity • Blockchain (MetaMask) •Bootstrap • Authentication & Authorization • Geocoding (MapBox & Google APIs) • Adobe CS • Sketch • Figma • InVision
EDUCATION
Le Wagon | Fullstack Ruby on Rails Developer Bootcamp | Milan, Italy | 01.2019 – 03.2019
• 9-week bootcamp focused on Ruby on Rails web development
• Skills: RoR, HTML, CSS, JavaScript, Front-End (Bootstrap), Git, DOM, AJAX, OOP, Advanced Routing, ActiveRecord, Hosting & Image Upload (Cloudinary), Authentication & Devise, Authorization & Pundit, Geocoding (MapBox, Google API’s), Search (Algolia), Payment (Stripe), Mailing, Background Jobs (Redis/Sidekiq), API, Test Driven Development (TDD), webpack.
• Projects: Social movie picker; a mobile-first web app for friends to discover shared movie interests to help plan group movie nights && Instrument rental marketplace (similar to the AirBnb user-journey)
M.Sc., Biomedical Technology Development & Management | Georgetown Univ. | Washington, DC, U.S. | 09.2009 - 05.2011
B.Sc., Biological Sciences | Virginia Tech | Blacksburg, VA, U.S. | 09.2005 - 05.2009
EXPERIENCE
Validant Consulting | Consultant, Medical Device Regulation | San Francisco, CA , U.S. | 09.2018 – 12.2018
• Updated product licenses to maintain European sales • Managed product documentation updates with client Engineering,
Marketing, & Clinical teams to meet European Directives (MDR 2.7/1 Rev. 4) • Completed the ‘General Safety and Performance
Requirements’ (GSPR) checklists assessing all aspects of the medical product design, clinical aspects, and post-market
surveillance • Performed Gap Analyses on the client design documentation • Tracked documentation in client Quality
Management system for SME tracking.
Johnson & Johnson | Regulatory Affairs Consultant | Irvine, CA, U.S. | 02.2017 – 09.2018
• Managed 30x registrations for Europe, China, Japan, Russia, and Brazil for all product lines • Revised European Technical
Files for Sterilizers and Disinfection capital equipment • Led calls with international affiliates to review registration updates and
timelines • Worked with SME’s (Engineering, Marketing, Supplier Quality, etc.) to meet various registration timelines
ZAETAE, Inc. | Founder & CEO | Boston, MA, U.S. | 10.2015 – 01.2017
• Awarded $30,000 grant from Startup Chile (Generation 15); www.startupchile.org • Managed the development of a multisided
platform connecting patients and providers worldwide - we helped patients find affordable medical treatment.
Implemented regulations for HIPAA and Personal Health Information (PHI) compliance • Hired remote team for development,
and legal incorporation
PENTAX Medical | Senior Regulatory Affairs Specialist | Montvale, NJ, U.S. | 03.2014 – 10.2015
• Licensed 50x international product licenses for endoscopes, colonoscopes, video processors and ENT devices • Performed
gap analysis of European CE-Mark compliance (e.g. Restriction of Hazardous Substances) and advised team on remediation •
Completed Regulatory Assessments to start design on a HIPAA / DICOM compliant software • Revised procedures (Design
Controls and Identification of New Standards) • Contributed to successful FDA Inspections & TÜV audit.
Ellman, International | Regulatory Affairs Associate | Hicksville, NY, U.S. | 02.2012 – 03.2014
• Contributed to four 510(k) submissions: a software update to an existing radiofrequency (RF) generator, an expanded indication (for wrinkle reduction among darker skin phototypes), a cellulite-reduction massage handpiece, and a laser lens intended for hair removal • Registered Radiofrequency surgical generators & aesthetic lasers in China, Europe, Korea, Japan, Canada, Israel, and Thailand • Prepared for FDA Inspections and TUV audits. Managed a recall (international and US) with the FDA.