- ADM (Kennesaw, GA)
- …primary QA authority during assigned shifts, ensuring compliance with cGMPs, FDA regulations, and internal quality systems while supporting production, warehouse, ... 3rd shift operations + Ensure compliance with cGMPs and FDA regulations including 21 CFR 111 and 117 +...QA Management **Required Skills:** + Strong knowledge of cGMPs, FDA regulations, and quality systems + Ability to make… more
- ZOLL Medical Corporation (Deerfield, WI)
- …that complies with relevant regulations and industry standards, such as ISO 13485 and FDA requirements. + Collaborate with other ACT quality site leads to ensure the ... industry, and ensure the site's compliance with all applicable regulations, including FDA , EU MDR, and other global regulatory requirements. + Establishes annual… more
- MetaOption, LLC (Jersey City, NJ)
- …Pharmaceutical Regulatory & Compliance Consultant with deep expertise in US FDA regulations, DEA requirements, and state-level compliance frameworks. The ideal ... standards. Key Responsibilities + Regulatory Compliance Oversight + Advise on FDA , DEA, and state regulatory requirements for pharmaceutical manufacturing and… more
- BD (Becton, Dickinson and Company) (San Diego, CA)
- …+ Coordinate, prepare, and complete premarket applications to the US FDA including Premarket Notification [510(k)] and Pre/Q-Sub submissions in a timely ... manner. Act as liaison with FDA regarding product submissions. + Assess US regulatory requirements...and completion of 510(k) submissions. + Experience collaborating with FDA personnel during 510(k) review and meetings with the… more
- ThermoFisher Scientific (Fremont, CA)
- …and production and laboratory standards are in compliance with all GMP, ISO, FDA , OSHA and other company manufacturing and safety guidelines. Ensures quality systems ... are effectively maintained to achieve strong levels of GMP/ISO/ FDA /OSHA compliance . Responsible for meeting financial targets, key measurements and benchmarks… more
- Kelly Services (Torrance, CA)
- …of finished product in accordance with Client's SOPs, cGMP standards, and FDA regulations. **Responsibilities:** + Follow detailed batch records to accurately weigh, ... process issues in real time. + Ensure compliance with FDA and GMP guidelines for OTC manufacturing. + Adhere...cosmetic and/or OTC manufacturing environment. + Solid understanding of FDA , GMP, and SOP requirements in a regulated manufacturing… more
- Chiesi (Cary, NC)
- …documents and submissions (eg, INDs, BLAs/NDAs, supplements, amendments, and responses to FDA information requests). + Conducting background research on FDA ... have + Coursework or prior exposure to regulatory affairs, FDA regulations, or drug development. + Familiarity with ...FDA regulations, or drug development. + Familiarity with FDA regulatory pathways (eg, IND, NDA, BLA, orphan drug… more
- University of Pennsylvania (Philadelphia, PA)
- …contrast agents, including Hyperpolarized Xenon-129. These studies are conducted under FDA IND/IDE oversight in partnership with industry sponsors. The CRC-C will ... ideal candidate will bring prior experience supporting clinical trials under FDA IND or IDE oversight, particularly those involving investigational imaging agents… more
- Insight Global (Pleasant Prairie, WI)
- …ISO 9001, ISO 13485, FSSC 22000, and applicable regulatory requirements including FDA 21 CFR Part 820. The Specialist will collaborate cross-functionally to ensure ... controlled documents meet ISO 9001, ISO 13485, FSSC 22000, FDA (21 CFR part 820), and applicable regulatory standards....ISO 13485, FSSC 22000, and applicable regulatory requirements including FDA 21 CFR Part 820 requirements. - Proficiency in… more
- University of Colorado (Aurora, CO)
- …and effective policies, procedures, and processes to facilitate investigator initiated, FDA regulated clinical research on campus in a compliant and customer ... strategic opportunities. + Proven track record managing INDs/IDEs and interacting with FDA + Experience in the academic research environment + A combination of… more