| Resume alert | Resumes 91 - 100 of 528 |
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
Manager Medical
Dorchester, MA
... SKILLS Calibration Chemistry CLIA Compliance FDA Hematology Inspection ISO/IEC 17025 Internal Audits Laboratory equipment Laboratory testing Personnel Policies Quality Assurance QA Quality Control Research Safety Surveys Technical support Validation ... - 2021 Mar 24
... SKILLS Calibration Chemistry CLIA Compliance FDA Hematology Inspection ISO/IEC 17025 Internal Audits Laboratory equipment Laboratory testing Personnel Policies Quality Assurance QA Quality Control Research Safety Surveys Technical support Validation ... - 2021 Mar 24
Project Analyst
Quincy, MA
... Became familiar with due diligence process including researching materials, developing a prototype, and complying with FDA regulations. Material selection was a focal point of this project. Automated Chest Compression Device January 2020-May 2020 ... - 2021 Feb 25
... Became familiar with due diligence process including researching materials, developing a prototype, and complying with FDA regulations. Material selection was a focal point of this project. Automated Chest Compression Device January 2020-May 2020 ... - 2021 Feb 25
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
Assistant Document Control
Norwood, MA
... FDA and ICH guidelines; the roles of CRA and CRC; the types of monitoring visits; the role of IRBs; Safety, Accountability, and Regulatory Compliance. Northeastern University, Level Program, Online Introduction to Data Analytics November 2018- ... - 2020 Dec 12
... FDA and ICH guidelines; the roles of CRA and CRC; the types of monitoring visits; the role of IRBs; Safety, Accountability, and Regulatory Compliance. Northeastern University, Level Program, Online Introduction to Data Analytics November 2018- ... - 2020 Dec 12
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