| Resume alert | Resumes 71 - 80 of 461 |
Software Consultant Developer
Andover, MA
... Automated data load from Oracle ERP system to Infomed SQL Server with FDA data feed option using DTS, SSIS and asp.net interface for tracking/export to excel and custom SSRS reports. Develop views using Razor markup for C# ASP.Net Web pages (CSS, ... - 2021 May 24
... Automated data load from Oracle ERP system to Infomed SQL Server with FDA data feed option using DTS, SSIS and asp.net interface for tracking/export to excel and custom SSRS reports. Develop views using Razor markup for C# ASP.Net Web pages (CSS, ... - 2021 May 24
Digital Copywriter Content Writer
Cambridge, MA
... of all web-related content in blog posts and articles Professional at crafting technical Food and Drug Administration (FDA) compliant articles for the Biotech industry Highly skilled Internet Research Specialist Expert in writing for the Health ... - 2021 May 04
... of all web-related content in blog posts and articles Professional at crafting technical Food and Drug Administration (FDA) compliant articles for the Biotech industry Highly skilled Internet Research Specialist Expert in writing for the Health ... - 2021 May 04
Medical Device
Boston, MA
... Regulatory Project Intern - Experiential Network Sep 2020 - Dec 2020 § Tasked in preparation of De Novo Application template per FDA guidance “De Novo Classification Process” § Prepared in-depth review of regulatory data & documentations for Adverse ... - 2021 Apr 06
... Regulatory Project Intern - Experiential Network Sep 2020 - Dec 2020 § Tasked in preparation of De Novo Application template per FDA guidance “De Novo Classification Process” § Prepared in-depth review of regulatory data & documentations for Adverse ... - 2021 Apr 06
Pharmacy Quality
Boston, MA
... strategy for oxycodone hydrochloride and acetaminophen tablets • Regulatory pathway presentation - Drafted the pathway strategy for a device called Hemoblast bellows including classification, pathway to FDA guidance and applicable timelines. ... - 2021 Apr 05
... strategy for oxycodone hydrochloride and acetaminophen tablets • Regulatory pathway presentation - Drafted the pathway strategy for a device called Hemoblast bellows including classification, pathway to FDA guidance and applicable timelines. ... - 2021 Apr 05
Student at Northeastern University
Lexington, MA
... 2020 • Teamed with system developments to build operation tools that facilitate FDA pharmaceutical surveillance • Implemented Django backend and Bokeh to develop application tools and visualizations for FDA Querying • Experienced Agile development ... - 2021 Jan 21
... 2020 • Teamed with system developments to build operation tools that facilitate FDA pharmaceutical surveillance • Implemented Django backend and Bokeh to develop application tools and visualizations for FDA Querying • Experienced Agile development ... - 2021 Jan 21
Engineer Data
Billerica, MA
... The BSC Gateway sends the eMDR 3500A XML files to the FDA Gateway using a secure digital certificate. The digital certificate identifies submissions from Boston Scientific Worked on URDs and Business requirements Worked on functional requirements to ... - 2021 Jan 18
... The BSC Gateway sends the eMDR 3500A XML files to the FDA Gateway using a secure digital certificate. The digital certificate identifies submissions from Boston Scientific Worked on URDs and Business requirements Worked on functional requirements to ... - 2021 Jan 18
Medical Quality
Boston, MA
... • Well versed with FDA Forms: 1571, 1572, 3674, 3454, 3455, 3500, 3500A, 3962, 483, Warning Letters and Type A, B, (Pre-IND &EOP 2), & C meetings. • Possess a thorough understanding and implementation of ISO 13485, ISO9001, ISO62304, and ISO14971 • ... - 2021 Jan 03
... • Well versed with FDA Forms: 1571, 1572, 3674, 3454, 3455, 3500, 3500A, 3962, 483, Warning Letters and Type A, B, (Pre-IND &EOP 2), & C meetings. • Possess a thorough understanding and implementation of ISO 13485, ISO9001, ISO62304, and ISO14971 • ... - 2021 Jan 03
Engineering Engineer
Andover, MA
... Maxtec is a medical company and we followed ISO 14971 standards for FDA approval and compliance. President, Excalibur Engineering LLC (1992 to 2004) Excalibur Engineering is a company I cofounded. My responsibilities included sales, manufacturing ... - 2020 Dec 18
... Maxtec is a medical company and we followed ISO 14971 standards for FDA approval and compliance. President, Excalibur Engineering LLC (1992 to 2004) Excalibur Engineering is a company I cofounded. My responsibilities included sales, manufacturing ... - 2020 Dec 18
Engineer Engineering
Boston, MA
... Performed validation and qualification of manufacturing equipment and processes leveraging standard qualification approaches (IQ/OQ/PQ/TMV/ETR) in compliance with FDA regulations and ISO 9001, ISO 14001 & OHSAS 18001 standards Key Results Include: • ... - 2020 Dec 13
... Performed validation and qualification of manufacturing equipment and processes leveraging standard qualification approaches (IQ/OQ/PQ/TMV/ETR) in compliance with FDA regulations and ISO 9001, ISO 14001 & OHSAS 18001 standards Key Results Include: • ... - 2020 Dec 13
Quality Service
Lowell, MA
... Familiarity with FDA Title 21, CFR820.100, CFR820.198, CFR803, ISO 9001, ISO 13485:2016, ISO 14971:2019, and other medical device regulations. Exceptional ability to handle multiple tasks and conduct with accuracy and high attention to detail. ... - 2020 Dec 10
... Familiarity with FDA Title 21, CFR820.100, CFR820.198, CFR803, ISO 9001, ISO 13485:2016, ISO 14971:2019, and other medical device regulations. Exceptional ability to handle multiple tasks and conduct with accuracy and high attention to detail. ... - 2020 Dec 10