- Abbott (Alameda, CA)
- …their glucose levels with our new sensing technology. **The Opportunity** This ** Regulatory Affairs Manager - International Compliance Operations** will ... way people monitor their glucose levels with our new sensing technology. This ** Regulatory Affairs Manager - International Compliance Operations** will… more
- Abbott (Santa Clara, CA)
- …device business units that Leveraged Services team supports. **The Opportunity** The **Senior Manager Regulatory Affairs** will work for our Global Regulatory ... ( FDA ) Center for Devices and Radiological Health (CDRH). This Senior Manager Regulatory Affairs may analyze broad scope implications of changing regulations,… more
- Kelly Services (Valencia, CA)
- …in a similar role. + Proven experience with 5 years or more of FDA submissions and international regulatory compliance . + Lead Auditor certification ... + ** Regulatory Affairs Manager ** + **Location:** Onsite...for a leading client. In this role, you'll ensure compliance with FDA , ISO, and international regulations… more
- Kelly Services (Torrance, CA)
- …is initially project-based, with the possibility of transitioning into a full-time Regulatory Manager role upon successful performance and cultural fit. **Key ... ** Regulatory Affairs Project Manager (Cosmetics &...manufacturing background is highly desirable. + In-depth understanding of FDA regulations, OTC drug monograph compliance , cosmetic… more
- BeOne Medicines (San Mateo, CA)
- **General Description:** The Manager , Regulatory Advertising and Promotion will be responsible for the review and approval of promotional materials for assigned ... functions in the United States and Canada to ensure compliance with applicable regulatory requirements and guidelines,...+ Maintains up to date information regarding initiatives by FDA , Health Canada, and other applicable regulatory … more
- Abbott (Santa Clara, CA)
- …imaging catheters and software, vessel closure devices and peripheral stents. This ** Regulatory Affairs Manager ** position is an onsite opportunity working out ... regulatory requirements to development and manufacturing teams + Prepare robust regulatory applications ( FDA and international regulatory agencies) to… 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 (Pleasanton, CA)
- …to restore their health and get on with their lives. As a Senior Quality Compliance Manager , the individual will play a crucial role within Abbott's Heart ... understand quality system requirements and how they impact product quality and regulatory compliance . + Represents the division within Abbott through Corporate… 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
- Medtronic (Irvine, CA)
- …new process documents + Monitor changes and compliance with applicable FDA and international regulatory laws/standards and the Medtronic Code of Conduct ... to ensure that it meets all medical, legal, and regulatory (MLR) process requirements. + Facilitate review meetings online...+ Excellent communication & organizing skills + Knowledge of FDA , EU, and TGA requirements + Knowledge of Neurovascular… more
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