- Abbott (San Diego, CA)
- … requirements. + Complies with US Food and Drug Administration ( FDA ) regulations, other regulatory requirements, Company policies, operating procedures, ... development, and validation of software for embedded systems, ensuring compliance with FDA requirements. They play a crucial role in software design, coding, and… more
- Takeda Pharmaceuticals (Los Angeles, CA)
- …Assurance activities for Teardown, Fractionation, and Purification following cGMP, GDDP, FDA and Regulatory Standards, ISO requirements, and internal standard ... Provide assessments to support good understanding and knowledge of current regulatory requirements ie, FDA , ISO, and Takeda Quality Systems, and serve as a plant… more
- Ascendis Pharma (Palo Alto, CA)
- …role involves engaging closely with internal peers and externally stakeholders such as the FDA , EMA, and other key regulatory bodies. The candidate must not only ... per year domestically and internationally + Broad experience in Regulatory Affairs, working directly with FDA and...experience in Regulatory Affairs, working directly with FDA and international agencies with focus on North and… more
- Abbott (Alameda, CA)
- …on future actions. + Complies with US Food and Drug Administration ( FDA ) and international regulations, other regulatory requirements, Company policies, ... levels with our new sensing technology. **The Opportunity** This ** Regulatory Affairs Manager - International Compliance Operations** will work...5 of those years related to the preparation of FDA submissions (PMA, IDE, 510(k)) for Class I, II,… more
- Stanford University (Stanford, CA)
- …to precision medicine in mental health and neuroimaging trials + Experience with FDA regulatory procedures and reporting + Demonstrated capacity to solve ... audit study forms for completion and accuracy with source documents. Prepare regulatory submissions and ensure Institutional Review Board renewals are completed. +… more
- Kelly Services (Sunnyvale, CA)
- …scope for the initial product launch (US, EU, WHO/PQ). + Authors and prepare regulatory submissions (US- FDA , IVDR, WHO/PQ) as required by project plan. + ... goals and meeting timelines + Compiling, preparing, reviewing, and submitting regulatory submissions including FDA pre-submissions, 510(k) and PMA submissions… more
- Abbott (Alameda, CA)
- …navigating complex regional regulations. + Compliance and Oversight: Ensure compliance with global regulatory standards (eg, FDA , EMA, ISO 13485, EU MDR) and ... devices or digital health solutions. + Extensive knowledge of global regulatory requirements, including FDA regulations (eg, 21 CFR Part 820), ISO 13485, and EU… more
- Meta (Burlingame, CA)
- …wrist wearables, and other innovative devices. **Required Skills:** Medical Devices, Regulatory Specialist Responsibilities: 1. Interact directly with FDA and/or ... **Summary:** We're seeking a regulatory affairs specialist to join our medical devices...vigilance reporting, product recalls, etc., as needed 3. Prepare FDA , European and Canada submissions for product changes as… more
- Unilever (El Segundo, CA)
- …with international markets. + Ensure timely filing and approval of all regulatory documentation, including FDA 30-Day Notifications, and support expansions into ... extraordinary hydration. **About the Role:** The Senior Director of Regulatory Affairs leads the Regulatory Affairs team...a minimum of 8-10 years + Deep understanding of FDA regulations, FSMA (21 CFR Part 117), DSHEA, and… more
- 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