- Fujifilm (Sacramento, CA)
- …+ Comply with all applicable US Food and Drug Administration (US FDA ) medical device regulatory requirements, applicable ISO 13485 standard requirements and all ... skills, self-starter a must along with ability to maintain paperwork to FDA and company required standards. + Excellent analytical and communication skills with… 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
- J&J Family of Companies (Santa Clara, CA)
- …software is required. + Intermediate statistical analysis experience is required. + Knowledge of FDA and ISO regulations preferred (ie FDA CFR Part 820 and/or ... ISO13485). + Ability to work independently as well as on a multifunctional team. + Excellent verbal and written communication skills. + Strong proficiency with SQL, experience with Databricks or other data lakehouse systems is also a plus. + Experience with… more
- Element Materials Technology (Santa Fe Springs, CA)
- …+ Assist in audit preparedness and for participating in quality audits with FDA , other Regulatory Agencies, and customers, as needed + Ensures work is in ... with all state and federal regulations, including but not limited to GMP, DEA, FDA , etc. **Skills / Qualifications** + Requires a minimum of a bachelor's degree in… more
- Actalent (Santa Clara, CA)
- …qualify designs according to established standards. + Ensure compliance with FDA regulations through proper documentation. + Operate within an ISO-certified Quality ... of Quality Management Systems (QMS) and ISO standards. + Familiarity with FDA documentation requirements. + Experience with JAMA, JIRA, and IEC standards. Additional… more
- Stanford University (Stanford, CA)
- …investigator to ensure Investigational New Drug applications are submitted to the FDA when applicable. Ensure Institutional Review Board renewals are completed. + ... protocols and regulatory or governing bodies, which include HIPAA and FDA regulations, Institutional Review Board requirements, and Good Clinical Practices. +… more
- Abbott (Sylmar, CA)
- …requirements. + Complies with US Food and Drug Administration ( FDA ) regulations, other regulatory requirements, Company policies, operating procedures, processes, ... and issue-tracking tools such as GIT, Jira, Subversion, ClearQuest, Doors, Bugzilla. + Knowledge of FDA 21 CFR part 820, 21 CFR part 11, GMP, IEEE 1012, IEC 62304… more
- Abbott (Sylmar, CA)
- …regulatory requirements. Complies with US Food and Drug Administration ( FDA ) regulations, other regulatory requirements, Company policies, operating procedures, ... ability to understand and comply with applicable Food & Drug Administration ( FDA ) regulations and Company operating procedures, processes, policies and rules is… more
- CSL Plasma (Fairfield, CA)
- …to monitor facility compliance with CSL procedures and policies, cGMP, OHSA, FDA , and other regulations, as applicable, and develop center responses for ... regulations and laws to include, but not limited to: ADA, Civil Rights, EEOC, FDA , GHA, HIPAA, and OSHA. + Maintain confidentiality of all personnel, donor and… more
- Stanford University (Stanford, CA)
- …investigator to ensure Investigational New Drug applications are submitted to the FDA when applicable. Ensure Institutional Review Board renewals are completed. _* - ... protocols and regulatory or governing bodies, which include HIPAA and FDA regulations, Institutional Review Board requirements, and Good Clinical Practices. +… more
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