- Amgen (Washington, DC)
- …alongside other innovative, driven professionals in this meaningful role. **Companion Diagnostic Regulatory Affairs Manager ** **Live** **What you will do** ... or Regulatory experience **Preferred Qualifications:** + MS Degree + Degree in Regulatory Affairs , Life Sciences, or Engineering + 6 plus years of experience… more
- BD (Becton, Dickinson and Company) (San Diego, CA)
- **Job Description Summary** As Manager , Regulatory Affairs , you will provide leadership to the MMS -Pharmacy Automation platform team. You will contribute to ... a plus** **RAC/RCC Certification preferred** **Minimum 4 years directly applicable recent regulatory affairs work experience (eg, IVD 510(k), PMA, de novo,… more
- Danaher Corporation (Washington, DC)
- …diagnostic tools that address the world's biggest health challenges. The Clinical Affairs Scientific Study Manager for Beckman Coulter Diagnostics is responsible ... time. You will be a part of the Clinical Affairs Team and report to the Senior Manager...+ Advanced knowledge of Good Clinical Practice and global IVD medical device + Experience developing regulatory … more
- BD (Becton, Dickinson and Company) (Sparks, MD)
- …platform/program area of focus and those of associated disciplines (such as R&D, Regulatory Affairs , Quality, Business, or Project Management). The Principal is ... platform/program area of focus and those of associated disciplines (such as R&D, Regulatory Affairs , Quality, Business, or Project Management). The Principal is… more
- Danaher Corporation (Raleigh, NC)
- …diagnostic tools that address the world's biggest health challenges. The Clinical Affairs Manager for Beckman Coulter Diagnostics is responsible for directly ... You will be a part of the CCIA Clinical Affairs team and report to the Senior Manager...the currently approved protocol/amendment(s), SOPs, GCP, PHI, and applicable regulatory requirements. + Drive clinical schedule deliverables and project… more
- BioFire Diagnostics, LLC. (Salt Lake City, UT)
- …R&D, projects and programs, strategic planning, product analytics, software, field staff, regulatory , legal affairs , compliance, and clinical and medical ... Lake City bioMerieux is looking for a Global Product Manager , to oversee systems software and connectivity of our...VOC to project proposal + Post market surveillance for IVD device functions + Technical guidance and specification on… more
- ThermoFisher Scientific (Cambridge, MA)
- …and influencing capabilities, with demonstrated experiences working with commercial, medical affairs , regulatory , compliance and other internal stakeholders + ... Market Access, Value and Evidence Team within Medical Scientific Affairs and will report to the Global Director, Market...from product concept and through the commercial process of IVD technologies developed by IDD + Support research, development… more
- ThermoFisher Scientific (Washington, DC)
- …visit** **https://www.thermofisher.com/bindingsite** **.** **Discover Impactful Work:** **The Sr. Manager , Health Economics and Outcomes Research (HEOR) & Real-World ... including dossier development and submissions, in collaboration with Medical & Scientific Affairs and Market Access colleagues. + Provide support and guidance to… more
- Abbott (Princeton, NJ)
- …Opportunity** Our location in Princeton, NJ currently has an opportunity for a ** Manager , Launch Excellence - TBI Launch Leader** . This is our cross-functional ... leadership, the sales team, contracts & pricing, marketing, medical affairs , field support services, commercial excellence, and operations. **ATTRACTIVE FEATURES… more
- Abbott (Irving, TX)
- …Ensure LMS records meet global compliance and audit-ready requirements for the IVD industry * Training Content Creation: Responsible for implementing and maintaining ... policies, and procedures and FDA regulations; include internal Quality and Regulatory compliance. * Relationship Building: Develop and cultivate relationships with… more