- Globus Medical, Inc. (Audubon, PA)
- …clearance for 510(k) submissions, and approval for IDE/PMA submissions to the Food and Drug Administration ( FDA ) for class II and class III products. This ... their lives as quickly as possible. **Position Summary:** The Regulatory Affairs Specialist assists with drafting, submitting and gaining...position entails development of FDA submissions, requires working knowledge of products under review… more
- Takeda Pharmaceuticals (Boston, MA)
- … submissions. + Solid working knowledge of drug development process and regulatory requirements. Knowledge of FDA , EU, Canada, ROW and post-marketing a plus. ... bring life-changing therapies to patients worldwide. The Associate Director Global Regulatory Affairs, Neuroscience is responsible for developing innovative global … more
- Medtronic (Minneapolis, MN)
- …develop solutions to complex US promotional issues. + Interact directly with FDA and/or indirectly with international regulatory agencies on most ... teams. + Provide feedback and on-going support to product development teams for regulatory issues and questions. + Prepare FDA , European and Canada submissions… more
- Kelly Services (Bridgewater, NJ)
- ** Regulatory Affairs Specialist - Advertising & Promotion** **Location:** Bridgewater, NJ / Hybrid **Pay Rate:** $61-$91/hour HYBRID **Overview:** We are seeking an ... experienced Regulatory Affairs Specialist with a focus on Advertising and...that all promotional activities adhere to applicable US laws, FDA regulations, and company policies, and collaborates cross-functionally to… more
- Abbott (Santa Clara, CA)
- …and other regulatory requirements. + Complies with US Food and Drug Administration ( FDA ) and international regulations, other regulatory requirements, ... product market entry. **What You'll Work On** + Prepares robust regulatory applications (either for FDA or for international regulatory agencies) to achieve… more
- Biomat USA, Inc. (Research Triangle Park, NC)
- …activities. **Knowledge, Skills and Abilities:** + Strong knowledge of Food and Drug Administration ( FDA ) regulatory requirements for good manufacturing ... policies / procedures. **Primary Responsibilities:** + Ensures compliance with Food and Drug Administration ( FDA ) regulations and all policies, guidelines, and… more
- Amneal Pharmaceuticals (Piscataway, NJ)
- …involving FARs and recalls. Essential Functions: + Will be the contact person for the FDA and other regulatory agencies in regard to Field Alerts responses and ... Field Alert & Recall Compliance is responsible for overseeing regulatory activities related to Field Alert Reports (FARs), product...Notifications as well as completes and issues to Illegitimate Drug Notification 3911 forms to FDA as… more
- Globus Medical, Inc. (Audubon, PA)
- …clearance for 510(k) submissions, and approval for IDE/PMA submissions to the Food and Drug Administration ( FDA ) for class II and class III products. This ... lives as quickly as possible. **Position Summary** **:** The Regulatory Affairs Associate assists in drafting, submitting and gaining...position entails development of FDA submissions, requiring working knowledge of products under review… 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 ... regulatory affairs strategies + Preferred experience with a drug device combination products + Extensive regulatory ...per year domestically and internationally + Broad experience in Regulatory Affairs, working directly with FDA and… more
- Regeneron Pharmaceuticals (Cambridge, MA)
- …Director might look like: + Responsible for the strategic company guidance on FDA and global regulatory requirements (affairs and CMC) for investigational and ... through lifecycle management. + Responsible for the strategic company guidance on FDA and global regulatory CMC requirements for investigational and commercial… more