- Oracle (Sacramento, CA)
- …EHR and AI-enabled medical device platforms. As a Clinical Product Manager (Medical Device Focus), you'll provide clinical insight into product design, ... Clinical Evaluation Reports (CERs), including alignment with EU MDR and FDA regulatory requirements. . Oversee usability engineering (IEC 62366), ensuring… more
- Oracle (Sacramento, CA)
- …EHR and AI-enabled medical device platforms. As a Clinical Product Manager (Medical Device Focus), you'll provide clinical insight into product design, ... Clinical Evaluation Reports (CERs), including alignment with EU MDR and FDA regulatory requirements. . Oversee usability engineering (IEC 62366), ensuring… more
- Astrix Technology (Los Angeles, CA)
- **Quality Assurance Manager ** Manufacturing Los Angeles, California, US + Added - 01/12/2025 Apply for Job Pay Rate Low: 90,000 | Pay Rate High: 95,000 Our client is ... line of skin care and color cosmetic products. Title: Quality Assurance Manager Location: Los Angeles, CA 90045 Schedule: M-F; 6:30am-3pm (Onsite) Salary:… more
- Actalent (Anaheim, CA)
- Job Title: Manager , Clinical Research FinanceJob Description The Manager of Clinical Research Finance is responsible for ensuring the strategic vision, ... compliance, and fostering communication between ministries, stakeholders, and leadership. The manager will also assist in developing and maintaining policies, as… more
- Edwards Lifesciences (Irvine, CA)
- …+ As a key member of the Medical Affairs Clinical Science team, the Senior Manager (formal internal title is Senior Manager , Medical Affairs) is responsible for ... a dynamic portfolio of products across TMTT. The Senior Manager will be an experienced medical device professional with...and EU MDR for clinical evaluations. + Experience with FDA PMA applications. + Strong knowledge of scientific research… more
- Otsuka America Pharmaceutical Inc. (Sacramento, CA)
- …products and drug-device combination products. Ensure compliance with global regulations ( FDA , EMA, ICH, WHO) and anticipate regulatory changes impacting CMC ... for investigational, marketed product submissions (IND/IMPD/NDA/MAA/DMF, post-approval supplements) for FDA and equivalent submissions for Europe and Canada. +… more
- Gilead Sciences, Inc. (Santa Monica, CA)
- …and help create more tomorrows. **Job Description** **Position Summary** The Manager , OOS & Expanded Access Program will lead the end-to-end Out-of-Specification ... and liaise with Kite Konnect operationalization team and the Kite Konnect Case Manager team to develop and implement integration for the sIND and EAP portal… more
- BeOne Medicines (San Mateo, CA)
- …authorities to deal with Logistics issues as needed, for example, Customs and FDA . + Coordinate internal or external functions for the Import and export permit ... in logistics audits as needed. + Support SCL on FDA inspection, internal audit and external audit as needed...in writing to all managerial directions. Consult with line manager in a timely manner if there are any… more
- Otsuka America Pharmaceutical Inc. (Sacramento, CA)
- The **Global Quality Audit Manager ** is responsible for planning, executing, and reporting on global audits to ensure **Good Clinical Practice (GCP) compliance** ... a key member of the Global Quality Management team, the Audit Manager will collaborate with cross-functional stakeholders to identify risks, drive continuous… more
- Gilead Sciences, Inc. (Foster City, CA)
- …day and improving the lives of patients for generations to come. The QA Manager (US market), a member of the Global Product Distribution & Affiliates (GPD&A) group, ... of Gilead Sciences Inc, and works closely with their manager as well as the Director QA (US) and...NAPB audits of Asegua as well as supporting external FDA audits and internal audit programs, as required +… more