- Grifols Shared Services North America, Inc (Los Angeles, CA)
- …plasma derived pharmaceuticals. + Strict adherence to procedures and practices according to FDA regulations. + Strong emphasis on documentation according to FDA ... + Minimum of 3 years of related experience in a pharmaceutical, GMP, or FDA regulated environment is required. + Demonstrated leadership skills with the ability to… 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
- BeOne Medicines (Emeryville, CA)
- …will interface with outside regulatory agencies and more specifically, the FDA , and business partners regarding development, regulatory, and registration strategies ... risk assessments, critical issue management and advice for the FDA and Health Canada interactions. + Uses extensive knowledge...local regulatory requirements + Liaises and negotiates with the FDA and Health Canada as needed for all aspects… more
- Grifols Shared Services North America, Inc (Los Angeles, CA)
- …area of responsibility. 21. Strict adherence to procedures and practices according to FDA regulations. 22. Strong emphasis on documentation according to FDA ... experience maintaining automated manufacturing systems and equipment, preferably in an FDA / GMP regulated environment. Experience with robotics, PLCs, PLC networks,… more
- Otsuka America Pharmaceutical Inc. (Sacramento, CA)
- …strategic planning of regulatory interactions and Provides tables and listings for FDA meeting briefing packages. + Support statistical needs for market access and ... Regulatory Affairs regarding study design and complex analysis issues, FDA issues, and general drug development. + Reviews clinical,...be applied on his/her assigned therapeutic area. + Attend FDA meetings, FDA advisory boards, or other… more
- Stanford University (Stanford, CA)
- …generate reports and prepare documents for submission as required by the IRB, FDA , OSP and APB requirements, including annual reports, and IND safety reports. The ... Cancer Clinical Trials Office (CCTO) for submission to the FDA according to established procedures. The position will gather,...Review Board (IRB), United States Food and Drug Administration ( FDA ), Office of Science Policy (OSP) and APB (Biosafety… more
- VTI Life Sciences (San Diego, CA)
- …environments are validated in compliance with industry standards, regulatory requirements (such as FDA 21 CFR Part 11 and 820, Data Integrity, ISO 13485 and GAMP ... and preliminary problem diagnosis. + Provide all services in accordance with FDA cGxP guidelines and regulations. QUALIFICATIONS: + Bachelor's degree or higher in… more
- Abbott (San Diego, CA)
- …risk assessments and contribute to risk mitigation strategies aligned with FDA and international cybersecurity guidance. + Implementation of security risk controls ... ComplieswithU.S. FoodandDrugAdministration ( FDA )regulations,otherregulatoryrequirements, Companypolicies,operatingprocedures,processes,andtaskassignments.… more