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Senior Director, Clinical Scientist -Neurodegenerative disease

Arvinas  –  New Haven, CT, 06540
... Food and Drug Administration (FDA) accepted the New Drug Application (NDA) for vepdegestrant- an investigational, orally bioavailable PROTAC estrogen receptor degrader- for its use as a monotherapy in the treatment of adults with estrogen receptor ... - Dec 03

Chemist Lab Lead

Starhired  –  Reidsville, NC, 27320
... A solid understanding of regulatory compliance is a must with FDA, USDA, AAFCO, cGMP. This is a full-time Direct Hire position. Must be a bench top chemist and used the analytical calculations manually with we chemistry on Food testing. ... - Dec 03

Quality Assurance and Compliance Specialist II

San Diego Blood Bank  –  San Diego, CA
... WHAT YOU NEED TO KNOW (Job Summary) Under the direction of the Manager, Quality & Regulatory Affairs, the Quality Assurance and Compliance Specialist II participates in maintaining a Quality Management System that supports the manufacture of FDA ... - Dec 03

General Counsel

Stowers Institute  –  Kansas City, MO, 64101
... Ensure compliance with federal, state, and international laws, including those specific to biomedical and life sciences research (e.g., IRS, FDA, NIH, HIPAA, GDPR). Oversee compliance programs and internal policies, particularly around research ... - Dec 03

Senior Clinical Database Programmer / Lead Clinical Database

Atorus Research  –  Radnor, PA
... Possesses a comprehensive understanding of regulatory guidelines and industry standards (e.g., ICH/FDA guidance, CDISC standards, GCDMP, 21 CFR 11, MedDRA, WHO Drug Dictionaries, etc.) and their application to Data Management practice. ? Attention ... - Dec 03

Quality Associate II

Katalyst Healthcares and Life Sciences  –  Medina, NY, 14103
... Experience in manufacturing/quality assurance engineering in an FDA regulated environment. Knowledge and working application of standard operating procedures. Knowledge and working application of FDA cGMP; ANSI/ISO/ASQC; CMDAS requirements. ... - Dec 03

Principal Design Quality Engineer - Digital (Remote)

North Carolina Staffing  –  Durham, NC, 27703
... Knowledge of medical device regulations (e.g., US FDA 21 CFR Part 820, ISO 13485, ISO 14971, IEC 62304, IEC 60601-1, FDA cybersecurity guidance). Salary: 115,600.00 to 245,800.00 plus bonus eligible + benefits. Individual pay is based on skills, ... - Dec 03

Principal Design Quality Engineer - Digital (Remote)

Philadelphia Staffing  –  Philadelphia, PA
... Knowledge of medical device regulations (e.g., US FDA 21 CFR Part 820, ISO 13485, ISO 14971, IEC 62304, IEC 60601-1, FDA cybersecurity guidance). 115,600.00 to 245,800.00 salary plus bonus eligible + benefits. Individual pay is based on skills, ... - Dec 03

Formulation Scientist R&D

Contract Pharmacal  –  Hauppauge, NY, 11788
... Skills and Abilities: Knowledge of cGMPs related to US FDA and EU EMEA manufacturing environments. Knowledge of Quality System requirements. Knowledge of ICH, USP, and EP requirements. Excellent oral and written communications skills, working ... - Dec 03

Mechanical Engineer I Waukesha, WI I Contract

Walker Healthforce  –  Waukesha, WI, 53188
... design, and electromechanical systems Bachelor's degree in Mechanical Engineering or a related field Strong understanding of FDA regulations, ISO 13485, and IEC 62304 Demonstrated ability to collaborate with suppliers, manage product testing and ... - Dec 03
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