- Oura (San Francisco, CA)
- …and lifecycle management for all regulated features. + Ensure compliance with FDA , CE (MDR), and other relevant global regulatory frameworks. + Review ... in consumer-facing wearables strongly preferred. + Proven track record of successful FDA submissions (510(k), De Novo) and international regulatory approvals. +… more
- Abbott (San Diego, CA)
- …guidance on regulatory requirements to development teams. + Manage preapproval compliance activities. + Formulate company procedures to respond to regulatory ... female executives, and scientists. **The Opportunity** This position, **Associate Director Regulatory Affairs** , works out of our **San Diego, CA** location… more
- Kelly Services (Torrance, CA)
- …contract manufacturing background is highly desirable. + In-depth understanding of FDA regulations, OTC drug monograph compliance , cosmetic labeling, product ... ** Regulatory Affairs Project Manager (Cosmetics & OTC Drug...full-time role. If you have a passion for ensuring compliance and expertise in the cosmetics and OTC drug… more
- Kelly Services (Anaheim, CA)
- …products. You will also serve as the Management Representative and Person Responsible for Regulatory Compliance under 21 CFR Part 111 and 117, while providing ... complete manufacturing and QA/QC process to ensure conformance and compliance and manage the Quality System in accordance with...USA and global regulations. + Proven experience interfacing with regulatory bodies such as FDA , Notified Bodies,… more
- BeOne Medicines (San Mateo, CA)
- …and other business functions in the United States and Canada to ensure compliance with applicable regulatory requirements and guidelines, and consistency with ... procedures, as necessary. + Maintains up to date information regarding initiatives by FDA , Health Canada, and other applicable regulatory authorities related to… more
- Gilead Sciences, Inc. (Foster City, CA)
- … regulatory initiatives focused on combination products and devices. Ensure regulatory conformance and consistency across markets, maintaining compliance with ... regulatory filings. Provide leadership for agency interactions, inspections, and regulatory responses. Ensure readiness and compliance for global… more
- Gilead Sciences, Inc. (Foster City, CA)
- …relevant experience. + BA/BS with 10+ years' relevant experience. + Significant regulatory , quality, compliance or related experience in the biopharma industry. ... Other Requirements** + In-depth understanding of US Food & Drug Administration ( FDA ) and European Medicines Agency (EMA) regulatory requirements and… more
- Grifols Shared Services North America, Inc (San Carlos, CA)
- …more than 110 countries and regions. **Summary:** Develops and implements worldwide regulatory programs for marketed products and/or those for development, and has ... interactions with regulatory authorities to expedite approvals. Participate in the development of, and leads/executes regulatory strategy and tactical decisions… more
- Abbott (Santa Clara, CA)
- … regulatory requirements to development and manufacturing teams + Prepare robust regulatory applications ( FDA and international regulatory agencies) to ... imaging catheters and software, vessel closure devices and peripheral stents. This ** Regulatory Affairs Manager** position is an onsite opportunity working out of… more
- BD (Becton, Dickinson and Company) (San Diego, CA)
- …requirements. + Review and approve labels, labeling, and promotional materials to ensure regulatory compliance . Assist in the collection of regulatory ... Directive, EU Electromagnetic Compatibility Directive, etc.). + Problem-solve and escalate regulatory and compliance issues to senior management as necessary.… more