- Abbott (Alameda, CA)
- …File (DHF) and Device Master Record (DMR) are in compliance with regulatory standards and quality management policies and procedures. + Collects, organizes, and ... such as medical devices or pharmaceutical products. + Knowledge of medical device standards including FDA QSR, ISO 13485, ISO 14971, 21 CFR Part 11 and IEC 62304. +… more
- Lactalis American Group Inc. (Tulare, CA)
- …equipment issues and develop long-term solutions. + Ensure compliance with all applicable regulatory and safety standards (eg, FDA , OSHA, USDA, GMP). + Develop ... equipment and process specifications, including sourcing vendors and managing installations or upgrades. + Maintain accurate documentation, including equipment manuals, drawings, SOPs, and project records. + Support plant utilities, including refrigeration,… more
- Cedars-Sinai (Los Angeles, CA)
- …all federal and local agencies including the Food and Drug Administration ( FDA ) and local Institutional Review Board. **Key Responsibilities:** + Coordinates data ... Excellent written and verbal communication skills. + Ability to strictly adhere to regulatory requirements and ethical guidelines. This role is designed to be 100%… more
- United Therapeutics (Sacramento, CA)
- …their daughter's pulmonary arterial hypertension (PAH). Today, we have six FDA -approved therapies that treat PAH, pulmonary hypertension associated with interstitial ... Knowledge of data entry processing, from start to finish (QC, medical review, regulatory submissions) + Prior clinical or post marketing experience **Job Location &… more
- Gilead Sciences, Inc. (Foster City, CA)
- …+ Hire, mentor and develop team members within the organization + Support regulatory filings by guiding the draft, review, and approval of CMC sections; support ... drug product development, commercial technology transfer to manufacturing, CMC related FDA and international regulations + Previous success working effectively in a… more
- Takeda Pharmaceuticals (Los Angeles, CA)
- …preferred + 5 years experience in a manufacturing environment preferred + FDA /cGMP experience preferred. + Must have demonstrated interpersonal and leadership skills ... statistical data. + Must have ability to understand cGMPs and other regulatory guidelines applicable to the medical/pharmaceutical industry. + Must have strong… more
- ThermoFisher Scientific (San Francisco, CA)
- …operations (scheduling, execution, NPI) are controlled and performed within cGMP regulatory guidelines and Thermo Fisher Scientific global quality standards. + ... commercial drug substance manufacturing, or commercial drug product manufacturing in an FDA regulated environment is required. + 5 years consistent track record of… more
- J&J Family of Companies (Santa Clara, CA)
- …Shockwave Medical's Quality Management System training program in accordance with FDA , European MDD/MDR, and ISO regulations. This position works with all ... duties as backup as required + Support Internal audits and third-party audits from regulatory agencies as the subject matter expert on the Training System + Other… more
- Kelly Services (San Ramon, CA)
- …of literature and other knowledge related to contact lenses. + Aware of basic regulatory requirements related to medical devices (GCP/ IRB / Design Control/ FDA ... & ISO standards/ EU MDR, etc.) and applies knowledge under direction of clinical management. + Conducts basic clinical assessments; serves as Sub-Investigator under direction of Principal Investigator. + Actively apply learnings from prior experience, current… more
- J&J Family of Companies (Santa Clara, CA)
- …for the treatment of calcified plaque. **Position Overview** In compliance with FDA , European MDD/MDR & ISO regulations, the Document Control Specialist II will ... maintenance of Direct Labor Competency Assessment Records when needed + Support Regulatory Assurance by assisting backroom activities during audits + May support… more