- J&J Family of Companies (Santa Clara, CA)
- …protocol and conducting compliance Assessment and system level validation. Assist with regulatory filings such as FDA 510(k) in accordance with Quality ... guidelines. **Requirements:** Employer will accept a Master's degree in Robotics, Mechanical Engineering, Electrical Engineering, or related field and 3 years of experience in the job offered or in a Robotics and Controls SW Engineer-related occupation This… more
- ThermoFisher Scientific (San Francisco, CA)
- …management preferred. **Knowledge, Skills, Abilities** + Demonstrable understanding of applicable regulatory requirements (ISO, ICH, FDA , EMA and USP) as ... it relates to analytical method transfer, phase-appropriate analytical method qualification and validation, safety testing and drug product stability. + Ability to build, use, and interpret scientific tables, charts, and graphs. + Able to read, comprehend, and… more
- Abbott (Sylmar, CA)
- …components and finished products to ensure they meet specifications and comply with regulatory requirements, such as FDA guidelines and ISO standards. + ... Troubleshoots and resolves production issues or discrepancies. Collaborates with other departments, such as engineering, quality, business excellence, and product development, to provide feedback on product design, manufacturability, process improvements, and… more
- Curia (Camarillo, CA)
- …skill in working in aseptic pharmaceutical environments + Prefer knowledge of cGMP and regulatory agencies (OSHA, EPA, FDA , JP, EU, etc.) requirements Pay Range ... $26.44 - $31.45/hr. Education, experience, location and tenure may be considered along with internal equity when job offers are extended. We do not accept unsolicited assistance from any headhunters or recruitment firms for any of our job openings. All resumes… more
- Gilead Sciences, Inc. (Foster City, CA)
- …translational science, biomarker strategy, and early clinical trial design. + Regulatory knowledge: Familiarity with FDA /EMA guidance for preclinical and ... early clinical phases. + CMC awareness: Understanding of drug substance/product development and manufacturing timelines. + Possess strong business acumen to align drug development and launch strategies with commercial goals, assess financial implications, and… more
- Terumo Neuro (Aliso Viejo, CA)
- …are met and consistent. + Audit data management vendors, as appropriate. + Assure regulatory compliance of vendors with company SOPs, FDA and ICH guidelines and ... accurate, high quality clinical data and adhering to Good Clinical Practices and FDA regulations. Job duties: + Develop and implement SOPs to ensure GCP/ICH… more
- Stryker (San Jose, CA)
- …and update internal SOPs and work instructions in response to evolving regulatory standards. + Support regulatory submissions (eg, 510(k)) and collaborate ... teams and authorities. + Participate in internal and external audits ( FDA , notified bodies), addressing sterilization and biocompatibility topics. + Apply ISO,… more
- Grifols Shared Services North America, Inc (Los Angeles, CA)
- …of product. Maintain a quality presence to ensure compliance with all regulatory requirements. Maintain current knowledge of regulatory and industry standards. ... performed for out-of-specification results or out-of-procedure events. Participate in regulatory and internal inspections/audits including providing written responses as… more
- Vera Therapeutics (Brisbane, CA)
- …governance, best practices, staff augmentation solutions, cost sheets, etc. Compliance & Regulatory Oversight * Ensure full compliance with FDA , EMA, GMP, ... with a strong focus on vendor selection and performance management, regulatory compliance, risk mitigation, contract oversight & management and operational… more
- CSL Plasma (Fairfield, CA)
- …This role will ensure compliance to training needs, SOPs, processes and other regulatory or company directives are adhered in order to support the operations and ... of required information. Initiate investigation and ensure documentation of regulatory deficiencies. Determine the need for corrective action, ensure appropriate… more