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FDA resumes in Arlington, MA

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Safety Specialist Regulatory Affairs

Boston, MA
... I worked for QA, gap analysis, and validation, with a strong focus on ensuring compliance with FDA regulations. I am now seeking a role as a Regulatory Affairs Associate in the biotechnology and medical device industries where I can leverage my ... - 2023 Jun 01

Award Winning/Rare Disease/Pharmaceutical Specialist Sales

Westwood, MA, 02090
... Key Accomplishment Earned second rank salesperson in a district of 12 salespeople Radiology Imaging Specialist /Lantheus Medical Imaging/Quintiles 2009-2011 Led sales and marketing for the first and only FDA-approved MRA Blood-Pool contrasting agent ... - 2023 May 21

Director, National Security & Emergency Management

Wellesley, MA, 02482
... Experienced compliance in the GCP and FDA procedures as well as proper disposal and documentation of hazardous materials; Oversaw and procure professional contracted services including security, grounds, facility system maintenance and repair; ... - 2023 May 20

RN

Framingham, MA
... What Every Health Care Provider Should Know About Patient Safety- Published in 2018 Co-Author Chapter 46 “Equipment Sequestration”- The process for sequestering malfunctioning healthcare equipment and FDA reporting processes - 2023 May 18

Regulatory Affairs Quality Supervisor

Malden, MA
... Studies, Boston, USA Jan 2021 – Dec 2022 MS in Regulatory Affairs for Drugs, Biologics, and Medical Devices Relevant Coursework: FDA Pharmaceutical and Medical Device Regulations, Pharmaceutical Engineering, Pharmaceutical and Medical Device Law, ... - 2023 Apr 17

Scrum Master Quality Engineer

Andover, MA
... Hardware and Software Design > 12 years Medical Devices > 10 years Cyber Security / PKI >5 years ISO 9001 > 10 years FDA 21 CFR Part 11, 210, 211, 820, HIPPA, ISO 9001 >5 years IEC 62304, IEC 82304, ISO 13485, EU Annex 11, EU MDR > 5 years AS9100 D. ... - 2023 Apr 14

Lab Technician Prior Authorization

Sudbury, MA
... • Understanding of applicable regulations, including FDA (21 CFR 312 and 314), ICH (E2A, E2B, E2C), GCP guidelines, EMA regulations, GVP Modules, etc. 2 Licensed Practical Nurse - July 2013 to present Pediatric nurse • Telephonic triage (assessment ... - 2023 Apr 13

Regulatory Affairs Intern

Boston, MA
... of eCTD Submission, Human Experimentation, Therapeutic Product Development, Regulatory Compliance and Practice, Introduction to FDA Pharma Regulation, Advertising and Promotional labelling, Pharma and Medical Device Law Jawaharlal Nehru Technology ... - 2023 Apr 05

Cinical Research Associate

Boston, MA, 02108
... s information into database and analyze research questionnaires/Graphs Maintained case files according to department, study, FDA requirements and working knowledge of ICH- GCP Reviewed safety study files for extraneous documents and to ensure ... - 2023 Mar 24

Service Representative Customer

Revere, MA
... Relations ● ● Patients Advocacy ● Microsoft office ● Patient Confidentiality ● Staff Development ● Problem-Solving Skills FDA and HIPAA Compliance ● Children's Developmental Clinic PHARMACY INTERN 06/2022 to 07/2022 Partners Pharmacy, Marlborough, ... - 2023 Mar 20
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