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Clinical Manufacturing Associate

Cynet Systems Inc.  –  Warren, NJ, 07059
... Experience within cGMP/FDA regulated industry. Basic mathematical skills. Technical writing capability. Proficient in MS Office applications. Background to include an understanding and application within industry of biology, chemistry, medical or ... - May 01

Clinical Manufacturing Associate - Est

Cynet Systems Inc.  –  Warren, NJ
... Experience within cGMP/FDA regulated industry. Basic mathematical skills. Technical writing capability. Proficient in MS Office applications. Background to include an understanding and application within industry of biology, chemistry, medical or ... - May 02

Vice President Regulatory Affairs Quality Assurance

EPM Scientific  –  Green Knoll, NJ, 08807
... Oversee the preparation, review, and submission of PMA applications to regulatory authorities, including the FDA. Provide guidance and expertise on regulatory requirements, standards, and best practices related to PMA submissions. Collaborate with ... - Apr 28

Quality Assurance Manager

Breckenridge Pharmaceutical, Inc.  –  Berkeley Heights, NJ, 07922
... systems, QA/QC Testing /Audit program, and Quality/Compliance decisions related to the Company’s ANDA products, as well as its products subject to OTC Monographs and FDA or other industry-accepted standards for Dietary Supplements and Medical Foods. ... - Apr 25

Director, US Regulatory Affairs Strategy

Daiichi Sankyo  –  Basking Ridge, NJ, 07920
... This role will work on one of our cutting-edge assets by effectively liaising, negotiating and partnering with FDA. This role will create and implement effective regulatory strategies to deliver on efficient and robust development plans. The ... - May 04

Aesthetic Area Sales Manager

Top Candidate Search Group  –  Morris Township, NJ, 07961
... Innovative technology using compact Lasers for 36 FDA indications. Description: Medical Device Aesthetic lasers Selling Capital equipment to Dermatology, Plastic Surgeons and Medical Spas Fast growing Sales organization, nice Culture! Company has ... - Apr 25

Quality Assurance Equipment/Computer System Validation Specialist II

BuildSubmarines.com  –  Raritan, NJ, 08869
... Knowledge of cGMP regulations and FDA/EU guidance related to manufacturing of cell-based products. Knowledge of Good Tissue Practices. Ability to pay attention to details and follow the procedures. Strong ability to prioritize assigned tasks in a ... - May 04

Senior Regulatory Affairs Associate

Breckenridge Pharmaceutical, Inc.  –  Berkeley Heights, NJ, 07922
... Under the direction of Regulatory Affairs management, participate in drug development from early stage development through final formulation, ensuring compliance with principles of Quality-by-Design, cGMP, and FDA rules and regulations Support new ... - Apr 10

CSV Consultant

Katalyst Healthcares & Life Sciences  –  Raritan, NJ, 08869
Responsibilities: Minimum 7 years' Experience in the Validating IT software systems like Quality Management System in Life Sciences industry Experience in FDA and/or Global regulated environment with good understanding of GxP standards like CFR 820 ... - May 02

Calibration Specialist

Mastech Digital  –  Raritan, NJ
... · Ensure site compliance with all local, state and federal regulations including and equivalent to Federal Drug Administration (FDA), Environmental Protection Agency (EPA), Occupational Safety and Health Administration (OSHA) as applicable. - Apr 28
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