- Actalent (Santa Clara, CA)
- …specifically within medical devices. + Experience with DHF, firmware, change orders, quality inspection plans, regulatory submissions, and design control. + ... design change orders. + Provide oversight on proper documentation for regulatory submissions. Essential Skills + Medical device experience and understanding of… more
- F & S Fresh Foods (Riverside, CA)
- …gold standard recipes, conduct sensory evaluations, and lead shelf-life testing with regulatory and quality assurance teams to ensure food safety, compliance, ... assessments for finished products and ingredients (as needed) and work with regulatory and quality assurance teams to ensure food safety and regulatory … more
- Ontic (Los Angeles, CA)
- …all manufacturing practices and recordkeeping are fully compliant with the applicable regulatory agency requirements. + Reduce quality costs, primarily focusing ... pace. Our team is looking for a Director of Quality Control to join them. You will report to...and a state of readiness for compliance for customers, regulatory compliance agencies, and other authorities. + Ensure that… more
- Otsuka America Pharmaceutical Inc. (Sacramento, CA)
- **Position Summary** Provides critical support in developing global regulatory strategy, planning and execution of global investigational and marketed prescription ... activities for all assigned projects in alignment with the Global Regulatory Lead. Translates complex pertinent global requirements and provides an assessment… more
- Abbott (Sylmar, CA)
- … regulatory professionals **Premarket:** + Assess the acceptability of quality , preclinical and clinical documentation for submission filing + Compile, prepare, ... regulated industry (eg, medical products, nutritionals). 2-5 years of experience in regulatory preferred but may consider quality assurance, research and… more
- Bausch + Lomb (Sacramento, CA)
- …B&L departments (eg, R&D/Project Management, Clinical/Medical Affairs, Biometrics, Regulatory Affairs, Quality Assurance, Pharmacovigilance/GPSS and Drug/Device ... ICH, GCP and B&L SOPs. + Responsible for the quality of all study-related documentation (eg, Trial Master File,...manage and monitor study related expenses to meet forecast. Regulatory Reports: + Provide Clinical Operations support in the… more
- Abbott (Alameda, CA)
- …Every day, our technologies help more than 10,000 people have healthier hearts, improve quality of life for thousands of people living with chronic pain and movement ... fingersticks. **The Opportunity** As an individual contributor in the function of a Regulatory Affairs Specialist you will provide support for the Regulatory … more
- Abbott (Santa Clara, CA)
- …regulated industry (eg, medical products, nutritionals). 2-5 years of experience in regulatory preferred but may consider quality assurance, research and ... imaging catheters and software, vessel closure devices and peripheral stents. This ** Regulatory Affairs Manager** position is an onsite opportunity working out of… more
- Abbott (Santa Clara, CA)
- … regulatory compliance. **Premarket:** + Assess the acceptability of quality , preclinical and clinical documentation for submission filing. + Compile, prepare, ... may compensate for years of experience. + 2-3 years of experience in regulatory preferred but may consider quality assurance, research and development/support,… more
- Ascendis Pharma (Palo Alto, CA)
- …advancing programs in Endocrinology Rare Disease and Oncology. The Sr. Director, Regulatory Affairs will serve as the therapeutic area head for assigned products ... and lead the US RA Strategy team. This role involves managing regulatory submissions and providing strategic leadership to ensure the successful design and execution… more