- Fujifilm (Sacramento, CA)
- …States. + Comply with all applicable US Food and Drug Administration (US FDA ) medical device regulatory requirements, applicable ISO 13485 standard requirements ... adapt to rapidly evolving situations and needs + Strong commitment to delivering high- quality work and upholding HCUS values. + Proficiency in Microsoft Word, Excel,… more
- Takeda Pharmaceuticals (Thousand Oaks, CA)
- …The position requires establishing and executing a vision that prioritizes safety, quality , and continuous improvement. You will report into the Head of Engineering. ... to safety guidelines and policies and enforcing compliance with California state, regulatory , and federal EPA regulations + Oversee the repair, maintenance, and… more
- Abbott (Sylmar, CA)
- …Support all initiatives as identified by management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other ... regulatory requirements + Aligns with US Food and Drug Administration ( FDA ) regulations, Company policies, operating procedures, processes, and task assignments… more
- Abbott (Pleasanton, CA)
- …Legal, Compliance, Finance, Education, Supply Chain, Research & Development, Regulatory , Quality , Clinical, Marketing, Commercial/Sales, and Information ... Claims Act, Civil Monetary Penalties Law, Stark, Beneficiary Inducement Statutes), FDA regulation (Food, Drug & Cosmetic Act), privacy (HIPAA), and anti-corruption… more
- Oura (San Francisco, CA)
- …our global community gain a deeper knowledge of their readiness, activity, and sleep quality by using their Oura Ring and its connected app. We've helped millions of ... + Collaborate with stakeholders in Product, Design, Science, Research, Data Science, Regulatory , Marketing and other teams across our global organization. + Mentor… more
- AbbVie (Irvine, CA)
- …Additional Requirements: * Responsible for performing all duties in compliance with FDA 's Quality System Regulation (QSR), ISO13485, the Canadian Medical Device ... Regulations, and all other international regulatory requirements with which ZELTIQ complies. Additional Information All your information will be kept confidential… more
- AbbVie (Pleasanton, CA)
- …Additional Requirements: * Responsible for performing all duties in compliance with FDA 's Quality System Regulation (QSR), ISO13485, the Canadian Medical Device ... Regulations, and all other international regulatory requirements with which ZELTIQ complies. Additional Information Applicable only to applicants applying to a… more
- Gilead Sciences, Inc. (Foster City, CA)
- …mAbs) CMC Analytical Development/Operations and IND/IMPD Submissions + Strong Understanding of FDA and ICH guidelines relating to registration, quality , and ... CMC process development, issue CoTs, seek Specfication endorsement, and author relevant regulatory filings (Phase I/II IND/IMPD) for biologic drug substance and drug… more
- Prime Matter Labs (Torrance, CA)
- …Degree in Chemistry or Chemical Engineering or a related field. + Familiar with regulatory standards such as ISO, GMP, or FDA . Preferred Skills: + ... will play a crucial part in optimizing manufacturing processes to enhance efficiency, quality , and productivity. This role requires a blend of technical skills and… more