- Abbott (Alameda, CA)
- …History File (DHF) and Device Master Record (DMR) are in compliance with regulatory standards and quality management policies and procedures. + Collects, ... serve people in more than 160 countries. **Job Title** ** Quality Engineer II** **Working at Abbott** At Abbott, you...pharmaceutical products. + Knowledge of medical device standards including FDA QSR, ISO 13485, ISO 14971, 21 CFR Part… more
- Bio-Techne (San Jose, CA)
- …to customers successfully. Collaborate with cross-functional teams (development, product management, regulatory ) to ensure quality is embedded throughout the ... years of hands-on technical project leadership in software development or software quality assurance and 5 years Agile software project management experience or… more
- Charles River Laboratories (Northridge, CA)
- …goals. + Ensure projects adhere to quality standards and relevant regulatory requirements (eg, GxP, FDA , ISO) **Job Qualifications** + Bachelor's degree ... internal workflows. + Collaborate with departments such as R&D, Quality , Regulatory , and Manufacturing to meet project...drugs approved by the US Food and Drug Administration ( FDA ) in the past five years. At Cell Solutions,… more
- Stanford Health Care (Palo Alto, CA)
- …the Pharmacy Quality Dashboard. Assist in maintaining dashboard. + Supports regulatory surveys and study monitor visits (IDS) as applicable. + Communicates and ... clinic managers, nurse managers, etc.) on medication-related issues such as regulatory changes/compliance, FDA drug recalls, drug information, sample… more
- Sumitomo Pharma (Sacramento, CA)
- …and achieve goals effectively. + Regulatory Engagement: Interface with regulatory authorities, including the FDA , EMA, and other global agencies, ... teams. Regulatory Interactions: + Prepare and present clinical data to regulatory agencies ( FDA , EMA) during IND submissions, clinical study reports, and… more
- VTI Life Sciences (San Diego, CA)
- …systems used in regulated environments are validated in compliance with industry standards, regulatory requirements (such as FDA 21 CFR Part 11 and 820, ... Engineering, Life Sciences, or related discipline. + 5+ years of relevant FDA -regulated industry experience. + Expertise in regulatory requirements and guidance,… more
- US Tech Solutions (San Bruno, CA)
- …Analysis, NC/CAPA, Audits) and US and International Medical Device Regulations & Regulatory Agencies (eg, FDA , Notified Bodies, etc.), and regulatory ... History File, and align with stakeholders. + Collaborate with Quality , Regulatory , Engineering, and UX teams to...Experience with medical device development standards eg ISO 13485, FDA 21 CFR 820 + Experience working with products… more
- Vera Therapeutics (Brisbane, CA)
- …governance, best practices, staff augmentation solutions, cost sheets, etc. Compliance & Regulatory Oversight * Ensure full compliance with FDA , EMA, GMP, ... tracking, and inventory optimization. Cross-Functional Collaboration * Partner with finance, regulatory , quality , R&D and manufacturing teams to ensure… 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 ... and developing and/or enhancing data management processes to ensure complete, accurate, high quality clinical data and adhering to Good Clinical Practices and FDA… more
- Grifols Shared Services North America, Inc (Los Angeles, CA)
- …equipment performance, facility layout, and quality of product. Maintain a quality presence to ensure compliance with all regulatory requirements. Maintain ... performed for out-of-specification results or out-of-procedure events. Participate in regulatory and internal inspections/audits including providing written responses as… more