- BioFire Diagnostics, LLC. (Salt Lake City, UT)
- …and Experience: Bachelor's Degree. Science background is preferred. 3+ years in regulatory affairs required, medical device/IVD industry preferred. ... A member of the RA team responsible for developing regulatory strategy and assessing regulatory risks for...worldwide approval. They may also perform and/or assist with medical device reporting or field actions. This position may… more
- J&J Family of Companies (Irvine, CA)
- …all relevant Clinical R&D partners and cross-functional partners (eg Global Strategic Marketing, Medical Affairs , Regulatory Affairs , Health Economics ... including during sponsor regulatory inspections. + In EMEA, responsible for Regulatory Affairs related tasks associated with clinical trials and evidence… more
- J&J Family of Companies (Raritan, NJ)
- …project delays and business critical competing priorities. + Provides strong connectivity with Medical Affairs , R&D, Regulatory Affairs , Preclinical ... Generation, will drive strategic implementation, adoption and oversight for Clinical Affairs project management activities for J&J MedTech Surgery. This individual… more
- Regeneron Pharmaceuticals (Tarrytown, NY)
- …CoE, QPPV office, etc. along with Regeneron areas including GD quality, vendor management, medical affairs , regulatory affairs , and other relevant ... operations, quality and compliance, planning, and assessing and implementing regulatory requirements, along with shown capabilities to lead cross-functional… more
- Takeda Pharmaceuticals (Lexington, MA)
- …research and program management experienced in leading cross-functional clinical programs within Medical Affairs , Clinical Research, Regulatory , CMC or other ... in all phases of development with significant experience within related functions (eg, Medical Affairs , Clinical Operations, Regulatory , CMC, Marketing). +… more
- Bausch + Lomb (Montgomery, AL)
- …with relevant global team members, other B&L departments (eg, R&D/Project Management, Clinical/ Medical Affairs , Biometrics, Regulatory Affairs , Quality ... in an accurate and timely manner. + Provide Clinical Operations support to the Regulatory Affairs department. Leadership: + Manage in-house team of CRAs, CTAs… more
- J&J Family of Companies (Irvine, CA)
- …all relevant Clinical R&D partners and cross-functional partners (eg Global Strategic Marketing, Medical Affairs , Regulatory Affairs , Health Economics ... to business plans. + Supports clinical scientific discussions with regulatory agencies/ notified bodies to drive support of the...CCRP, RAC, CDE, GCP, ISO 14155, MDR, MEDDEV). + Medical device experience highly preferred. + CRO experience and… more
- Bristol Myers Squibb (Madison, NJ)
- …Access objectives + Work as part of cross-functional teams-including clinical development, medical affairs , regulatory , and biostatistics-to ensure HEOR ... BMS leadership + Prepare relevant sections of documents and communications for regulatory agency meetings, support and/or participate in said meetings at … more
- AbbVie (North Chicago, IL)
- …authority across divisions (including Global Commercial Leaders, Forecasting, Clinical Development, HEOR, Medical Affairs and Regulatory , as well as peer ... Intelligence, Government Affairs , Global Marketing, Global Commercial Development, Global Medical Affairs and complimentary Area & Affiliate Functions, to… more
- BD (Becton, Dickinson and Company) (Salt Lake City, UT)
- …a relentless drive for results. Cross-Functional Collaboration: + Partner with Marketing, Medical Affairs , Regulatory , Operations, Quality, Finance, Legal ... and related clinical environments + Previous experience with heavy consumable/disposable medical devices. + Strong grasp of global regulatory requirements… more