- Abbott (Pleasanton, CA)
- …work environment. + Comply with US Food and Drug Administration ( FDA ) regulations, other regulatory requirements, Company policies, operating procedures, ... Management System compliance to internal policies, applicable standards and external regulatory requirements. **What You'll Work On** + The incumbent defines and… more
- Abbott (Temecula, CA)
- … requirements. + Complies with US Food and Drug Administration ( FDA ) regulations, other regulatory requirements, Company policies, operating procedures, ... and vendors. + Complies with US Food and Drug Administration ( FDA ) regulations, other regulatory requirements, Company policies, operating procedures,… more
- Gilead Sciences, Inc. (Foster City, CA)
- …The ideal candidate will possess deep expertise in SAP BRH & SAP QM module, regulatory compliance (such as GxP and FDA ), and life sciences Quality Management and ... comply with relevant Life Sciences industry regulations, including GxP, FDA , EMA, and other regulatory bodies. +...regulations, including GxP, FDA , EMA, and other regulatory bodies. + Lead the development of validation strategies… more
- Meta (Burlingame, CA)
- …approvals 2. Prepare, submit, and manage regulatory filings across global regulatory agencies including FDA and EU submissions 3. Provide expertise on ... **Summary:** As a Regulatory Affairs Lead, you will play a key role in ensuring regulatory compliance and supporting the global market expansion of products… more
- BD (Becton, Dickinson and Company) (Milpitas, CA)
- …on-time quality assessments, medical device reporting and health risk assessments to the FDA and other regulatory bodies + Provide subject matter expertise into ... clinical trials for medical device development and submission to the FDA and other regulatory bodies + Identify and communicate key development goals and… more
- ABM Industries (Carlsbad, CA)
- …to the development, implementation and effectiveness of Quality Management System per ISO, FDA , and other regulatory agencies. + Understands and is aware of ... of Quality system requirements, as well as internal and regulatory audits. + Ensure compliance with all Facilities and...Remain knowledgeable of current federal and international regulations, including FDA 21CFR part 820, FDA 21CFR part… more
- Abbott (Alameda, CA)
- … requirements. + Complies with US Food and Drug Administration ( FDA ) regulations, other regulatory requirements, Company policies, operating procedures, ... the requirements of the quality system, as well as FDA , ISO, MDD, CDR, MHLW, and other regulations applicable...industry + Min 8 years auditing per ISO and/or FDA standards. + Knowledge of MDD, CMDR, MHLW, TGA,… more
- Abbott (Sylmar, CA)
- … requirements. + Complies with US Food and Drug Administration ( FDA ) regulations, other regulatory requirements, Company policies, operating procedures, ... systems are developed, validated and maintained in compliance with regulatory and business procedures. As a global leader in...GIT, Jira, Subversion, ClearQuest, Doors, Bugzilla. + Knowledge of FDA 21 CFR part 820, 21 CFR part 11,… more
- Globus Medical, Inc. (San Diego, CA)
- …product managers to develop forecasts and market plans + Assist in the writing of regulatory applications to the FDA and other regulatory bodies. + ... product development + Create and maintain project plans and FDA complaint Design history Files (DHF) for each project...full compliance with Globus quality system and other applicable regulatory bodies + Design and develop instruments and implants… more
- Abbott (Sylmar, CA)
- … requirements. + Complies with US Food and Drug Administration ( FDA ) regulations, other regulatory requirements, Company policies, operating procedures, ... blueprint reading and experience with inspection sampling techniques. Knowledge of FDA , GMP, ISO 13485. Good communication and computer skills, including Microsoft… more