- Wacker Chemical (Ann Arbor, MI)
- …Affairs Specialist- FDA Food 1 1. This position is responsible for leading FDA regulatory product compliance reviews for Food Additive, Food Contact, and ... Contact, and Dietary Supplements, including maintaining our food facility registrations. The FDA Regulatory Affairs Specialist will evaluate and respond to… more
- Family Dollar (Chesapeake, VA)
- …industries (pharmaceutical or medical device industry preferred). . Working knowledge of FDA Quality Systems (cGMP) and regulatory requirements (eg, 21 CFR ... result of a complaint or event. . Oversee the regulatory notification process (eg, market actions such as Medical...with Company policies, procedures, and practices, as well as regulatory requirements. . Prepare the Annual Product Reviews (APRs)… more
- Family Dollar (Chesapeake, VA)
- …industries. (pharmaceutical or medical device industry preferred). + Working knowledge of FDA Quality Systems (cGMP) and regulatory requirements (eg, 21 CFR ... purchasing specifications against applicable standards to confirm conformance with regulatory requirements. + Assist in the vendor/supplier qualification program,… more
- RWJBarnabas Health (West Orange, NJ)
- …years of legal experience, including substantial experience with clinical research, FDA regulatory compliance, and research contracting + Comprehensive knowledge ... Assistant Vice President of Legal Affairs, Clinical Research & Regulatory ComplianceReq #:0000206242 Category:Professional / Management Status:Full-Time Shift:Day Facility:RWJBarnabas… more
- Oura (San Francisco, CA)
- …privacy and regulatory compliance with commercial objectives. What you will do: FDA & Global Regulatory Compliance: + Serve as the primary legal advisor ... risk for wearable-based health technology. + Provide strategic counsel on FDA oversight, regulatory submissions, and compliance strategies for biometric… more
- GRAIL (Menlo Park, CA)
- …advanced degree may count toward years of experience. + Direct experience with FDA regulatory submissions required. + Experience with regulatory submissions ... information, please visit grail.com . The role assists with regulatory strategy and the development of submissions in partnership...and activities to optimally position GRAIL products with the FDA and/or global health authorities. + Support the US… more
- Boehringer Ingelheim (Ridgefield, CT)
- …two (2) specialized areas of pharmaceutical law, one of which must be FDA Regulatory (eg, patient support programs, market access, patient assistance support) ... programs, access, Specialty Care/ Rare Disease pharmaceutical products. + Experience in FDA prescription drug regulatory matters including experience in the… more
- Xcelerate Solutions (Frederick, MD)
- …trend knowledge points and risks through the medical portfolio + Track and trend FDA regulatory intelligence + Assist with full lifecycle project management and ... Program Analyst IV - Medical Regulatory & Acquisition Strategy Xcelerate Solutions is seeking...for pharmaceutical development and within the constraints of the FDA approval process + Plan and provide input to… more
- Medtronic (Mounds View, MN)
- …requiring regulatory agency review. Prepare submissions and reports for FDA or provide support and documentation for global submissions. + Maintain proficiency ... an extended core team member. + Assist in negotiations with the FDA or other regulatory agencies for assigned projects. + Other tasks, as assigned. **Must Have:… more
- Boehringer Ingelheim (Ridgefield, CT)
- …personnel, will liaise with FDA in written communication and participate in FDA meetings on regulatory issues. Will support/assist in the preparation of ... cross-functional teams for FDA interactions on regulatory issues and provide guidance on preparation of briefing packages. + DMFs: Act as US Agent for BI's Type… more