- 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 ... Center for Devices and Radiological Health (CDRH). This Senior Manager Regulatory Affairs may analyze broad scope...+ Communicates with internal groups to share updates on regulatory changes as it pertains to the FDA… more
- Abbott (Alameda, CA)
- …their glucose levels with our new sensing technology. **The Opportunity** This ** Regulatory Affairs Manager - International Compliance Operations** will work ... their glucose levels with our new sensing technology. This ** Regulatory Affairs Manager - International Compliance Operations**...+ Assist in SOP development and review + Provide regulatory input to product lifecycle planning +… more
- Kelly Services (Valencia, CA)
- …two facilities. **Key Responsibilities:** + Oversee regulatory submissions ( FDA , EU MDR, international). + Maintain product registrations, certifications, ... + ** Regulatory Affairs Manager ** + **Location:** Onsite...+ Proven experience with 5 years or more of FDA submissions and international regulatory compliance. +… more
- Abbott (Alameda, CA)
- …monitor their glucose levels with our new sensing technology. **The Opportunity** This ** Regulatory Affairs Manager ** will work on-site in Alameda, CA for our ... glucose levels with our new sensing technology. As the Regulatory Affairs Manager , you will combine your...develop and manage regulatory professionals. + Provide regulatory input to product lifecycle planning. Monitor… 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 ... expert resource and mentor within the department. **WHAT YOU'LL DO** + Provide regulatory input to product lifecycle planning. Provide strategic input and… 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 &...FDA regulations, OTC drug monograph compliance, cosmetic labeling, product claims, and related documentation. + Demonstrated experience managing… 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 ... + Maintains up to date information regarding initiatives by FDA , Health Canada, and other applicable regulatory ...+ Minimum of two years of experience in a Regulatory ad/promo directly reviewing promotional materials. Product … more
- Grifols Shared Services North America, Inc (San Carlos, CA)
- …and initiatives that significantly impact the business. + Advises Management on regulatory aspects of product development and/or lifecycle management. Identifies ... more than 110 countries and regions. **Summary:** Develops and implements worldwide regulatory programs for marketed products and/or those for development, and has… more
- Meta (Burlingame, CA)
- …wrist wearables, and other innovative devices. **Required Skills:** Medical Devices, Regulatory Specialist Responsibilities: 1. Interact directly with FDA and/or ... at reviewer level. All significant issues will be reviewed with the manager 2. Support regulatory compliance activities, including site registration, audits,… more
- Meta (Burlingame, CA)
- …launch and expand our products in global markets by navigating complex regulatory landscapes and driving successful product registrations. **Required Skills:** ... strategies for novel and predicate Over-the-Counter software devices to achieve timely product approvals 2. Prepare, submit, and manage regulatory filings across… more