- Abbott (San Diego, CA)
- …implementation of cloud solutions** . Working closely with local and remote software engineering teams (international) developing software products and platforms ... a focus on details and collaboration with the cloud software development team. The Cloud Technical Lead should demonstrate...ISO 14971, IEC 62304, 21 CFR part 820.30-Design Controls, FDA SW Guidelines ). + Experience in delivering products… more
- ThermoFisher Scientific (West Hills, CA)
- …& Risk Management** + Ensure the team, process, and systems align with applicable regulations ( FDA , 21 CFR Part 820, Part 11, ISO 13485, IVDR, ISO 17025). + Own or ... support equipment/ software validation protocols and risk assessments (eg, FMEA). +...(eg, FMEA). + Support internal and external audits (eg, FDA , Notified Bodies). **Multi-Functional Collaboration** + Partner with R&D… more
- Element Materials Technology (Santa Fe Springs, CA)
- …and regulatory standards. The role requires a deep understanding of GMP, ISO 17025, FDA , and ICH requirements, as well as the ability to apply these standards to ... QA role + Strong knowledge of GMP, ISO 17025, FDA , EMA, and ICH guidelines + Experience in reviewing...stressful environment + Proficient with Microsoft Office Suite related software \#LI-TK1 **Company Overview** Element is one of the… more
- Otsuka America Pharmaceutical Inc. (Sacramento, CA)
- …understanding of the drug development process, laws, regulations, and guidelines including FDA , ICH, etc. - Able to successfully interpret and apply regulatory ... etc.) in pharmaceutical or healthcare related industry. Experience with FDA or other health authority interactions desirable. **Competencies** **Accountability for… more
- Abbott (Sylmar, CA)
- …regulatory requirements. Complies with US Food and Drug Administration ( FDA ) regulations, other regulatory requirements, Company policies, operating procedures, ... as telephone, fax/copier, and a personal computer with standard office software . **Working Conditions:** Works in a production or air-conditioned clean-room… more
- Bausch Health (Los Angeles, CA)
- …Maintaining compliance with all applicable quality and regulatory guidelines including FDA and corporate guidelines. + Supporting company goals, objectives, policies ... consumables or medical products to plastic surgeons or dermatologists in a FDA regulated, highly controlled environment. + Ideal candidates will also have knowledge… more
- UCLA Health (Los Angeles, CA)
- …study protocol and applicable regulations, such as institutional policy and procedures, FDA Code of Federal Regulations (CFR), and ICH Good Clinical Practice (GCP). ... use of spreadsheets, email, data entry. Ability to navigate numerous software programs and applications. + Ability to handle confidential material information… more
- Owens & Minor (Shingle Springs, CA)
- …+ Valid driver's license. + Must meet job-related requirements to comply with DOT, FDA and standards of accrediting body. + Current MVR must meet company minimum ... **PREFERRED QUALIFICATIONS** **Education and/or Experience** + Knowledge of DOT and FDA regulations + Knowledge of Home Healthcare industry + Two years… more
- Owens & Minor (El Segundo, CA)
- …driver's license required. + Must meet job-related requirements to comply with DOT, FDA and standards of accrediting body. + Current MVR must meet company minimum ... Knowledge of warehousing and inventory management + Knowledge of DOT and FDA regulations preferred + Knowledge of Home Healthcare industry preferred **Computer… more
- Meta (Burlingame, CA)
- …our medical devices compliance team. You will get to work on wearables and Software as a Medical Device (SaMD) applications for the US and worldwide approvals.You ... Medical Devices, Regulatory Specialist Responsibilities: 1. Interact directly with FDA and/or indirectly with international regulatory agencies on most… more