- Bristol Myers Squibb (Princeton, NJ)
- …careers.bms.com/working-with-us . A member of the Submissions team of the Specialist level in US Commercial Regulatory Affairs Operations (CRA Ops) supports ... tasks, primarily through the submission of Promotional Material to the FDA. The Submissions team member is responsible for the review and approval of submissions… more
- Medtronic (Irvine, CA)
- …reports, and ensuring that our product technical documentation is current and accurate. ** SENIOR REGULATORY AFFAIRS SPECIALIST - NEUROVASCULAR** In the ... compassionate world. **A Day in the Life** The Sr Regulatory Affairs Specialist will play a key...the international regulatory affairs group to support regulatory submissions . Sustaining regulatory responsibilities… more
- Grifols Shared Services North America, Inc (Clayton, NC)
- …products. + Prepare responses to regulatory agency inquiries. + Compile regulatory submissions through coordination with other departments and research of ... a team member in the product manager area of Regulatory Affairs (Biopharma) supporting global submissions for...a very timely and accurate manner. **_Sr Reg Affairs Specialist I_** **Primary responsibilities for role:** + Act as… more
- Globus Medical, Inc. (Audubon, PA)
- …can resume their lives as quickly as possible. **Position Summary** **:** The Senior Regulatory Affairs Specialist drafts, submits and gains clearance ... for 510(k) submissions , and approval for IDE/PMA submissions to the Food and Drug Administration (FDA) for...and PMA reporting + Reviews Document Change Orders for Regulatory compliance, including drawings and labeling changes + Performs… more
- West Pharmaceutical Services (Exton, PA)
- Senior Specialist , Regulatory Affairs...of data and or reports to be incorporated into regulatory submissions to ensure scientific rigor, accuracy, ... including Premarket Notifications and Technical Documentation for CE Marking. The Senior Specialist ensures timely and high-quality execution of all… more
- Abbott (Santa Clara, CA)
- …catheters, imaging catheters and software, vessel closure devices and peripheral stents. This ** Senior Regulatory Affairs Specialist ** position is an onsite ... Division. As an individual contributor, the function of a Senior Regulatory Affairs Specialist is...for submission filing. + Compile, prepare, review and submit regulatory submissions to authorities. + Monitor impact… more
- Hologic (Newark, DE)
- Senior Regulatory Affairs Specialist Newark, DE, United States **Join us as a Regulatory Affairs Specialist -Sustaining, and play a pivotal role in ... with R&D, Quality, Clinical, and Marketing, you will prepare and manage regulatory submissions , technical files, and documentation to meet US, EU, and Canadian… more
- Stryker (Redmond, WA)
- We are currently seeking a ** Senior Regulatory Affairs Specialist ** to join our **Medical** **Division** to be based **Hybrid** Monday through Wednesday in ... and compliance requirements (local, national, international) + Prepare and submit regulatory submissions (electronic and paper) in accordance with applicable… more
- Abbott (Plymouth, MN)
- …get on with their lives. **The Opportunity** Abbott is seeking a passionate, experienced ** Senior Regulatory Affairs Specialist ** to join our team on-site in ... affiliates. + Compile, prepare, review and submit medical device submissions to regulatory agencies + Interfaces directly with FDA and other regulatory… more
- Danaher Corporation (New York, NY)
- …Business System (https://www.danaher.com/how-we-work/danaher-business-system) which makes everything possible. The Senior Regulatory Affairs Specialist I ... for for pre-market regulatory affairs activities. The Senior Regulatory Affairs Specialist I...have the opportunity to: + Develop and execute global regulatory strategies, including FDA 510(k), Pre- Submissions , Health… more