- Kelly Services (Gillette, WY)
- …and launching a state-of-the-art research laboratory dedicated to shaping the future of healthcare . As a **Senior FDA Regulatory Affairs Specialist** , ... more
- Regeneron Pharmaceuticals (Sleepy Hollow, NY)
- …development through commercialization, including advising on a broad range of healthcare regulatory matters, including labeling negotiations, advertising and ... more
- DLA Piper (Washington, DC)
- …work and grow your career. Let's see what we can achieve. Together. **Summary** The Healthcare Regulatory Group is seeking a Healthcare Associate with 3-5 ... more
- Rush University Medical Center (Chicago, IL)
- …engineering program, including vendor oversight. Strong knowledge of Joint Commission, CMS, FDA , and other healthcare regulatory standards. Experience with ... more
- BeiGene (San Mateo, CA)
- …**Essential Functions of the job:** + Uses extensive knowledge of the US FDA regulatory environment and the ability to apply knowledge both strategically ... more
- Houston Methodist (Houston, TX)
- …study team and sponsor's regulatory team. This position communicates with regulatory affairs office for FDA submissions across multiple studies of different ... more
- J&J Family of Companies (Spring House, PA)
- …plans including BLA/NDAs, IND/CTAs & supplements. + Serve as primary point of contact for US FDA + Lead the regulatory response team for FDA and Health ... more
- IQVIA (Falls Church, VA)
- …in both the guidance and the practice of developing strategies and evidence to engage US FDA , the EMA and other regulatory agencies on COA endpoints and the use ... more
- BD (Becton, Dickinson and Company) (San Diego, CA)
- … affairs, with a focus on medical device systems + Knowledge of international regulatory requirements (eg, FDA QSR, ISO 13485, IEC 62304) + Solid understanding ... more
- Takeda Pharmaceuticals (Lexington, MA)
- …**Job Description** Join Takeda as an Associate Director, US Advertising & Promotion Regulatory Review out of our Lexington, MA or Exton, PA office. Where you ... more
- Integra LifeSciences (Braintree, MA)
- …Reports, 30 Day Notices, and 180 Day Submissions in accordance with US FDA requirements. + Interact with Regulatory Body personnel with minimal supervision. ... more
- Houston Methodist (Houston, TX)
- …and the International Conference on Harmonization (ICH). This position communicates with regulatory affairs office for FDA submissions across multiple studies of ... more
- Globus Medical, Inc. (Audubon, PA)
- …team is inspired by the needs of these patients, and the surgeons and healthcare providers who treat them. We embrace a culture of exceptional response by partnering ... more
- Sanofi Group (Cambridge, MA)
- …US Regulatory strategies (eg, submissions, product defense, labeling development, FDA enforcement, clinical trial support, FDA contacts). + Provide ... more
- Interstate Blood Bank (Vista, CA)
- …GBS DDL. * Assist Regulatory Management with product deviation reporting to the FDA . * Updates and distributes annual facility FDA reports. * Assists with ... more
- UTMB Health (Galveston, TX)
- …that utilize the US FDA GLP regulations as a reference standard. The Regulatory Scientist I / II may also function as a Principal Investigator for extramurally ... more
- Sanofi Group (Morristown, NJ)
- **Director, Global Switch Regulatory ** + Location: Morristown, NJ (Hybrid) **About the job** Are you ready to shape the future of Consumer Health? Your skills could ... more
- Philips (Bothell, WA)
- …fit if:** + You've acquired a minimum of 7 years' experience in Regulatory Affairs within FDA regulated medical device/software (SaMD, SiMD) environments, ... more
- Abbott (Plymouth, MN)
- … affiliates. + Compile, prepare, review and submit medical device submissions to regulatory agencies + Interfaces directly with FDA and other regulatory ... more
- Stryker (Tempe, AZ)
- …you will also ensure regulatory compliance through the maintenance of regulatory documentation and support review by FDA , Notified Bodies and other ... more