- GRAIL (Concord, NH)
- …other relevant documentation. The role collaborates cross-functionally with Quality, Lab Operations , and other stakeholders to support regulatory strategy ... For more information, please visit grail.com . The role assists with regulatory strategy and the development of submissions in partnership with key internal and… more
- Sanofi Group (Morristown, NJ)
- **Job title** : Global Regulatory Affairs Device Lead (Associate Director ) **Location** : Morristown, NJ or Cambridge, MA or Framingham, MA **About the Job** Are you ... supporting the medical device, combination product, digital health and in-vitro diagnostic ( IVD ) products within the Sanofi portfolio of products. The team is part… more
- Bristol Myers Squibb (Princeton, NJ)
- …personal lives. Read more: careers.bms.com/working-with-us . **Position Summary** The Director of Early Precision Medicine Regulatory Affairs leads global regulatory ... strategy for biomarkers and diagnostics, focusing on early-stage development...of the Translational Medicine CLIA Laboratory Steering Committee, the director drives coordinated early-stage drug-diagnostic strategies and health authority… more
- Abbott (San Diego, CA)
- …important information for treatment and management of diseases and other conditions. The Director , AI, Algorithms & Intelligent Architecture is a key member of the ... for building and developing an AI team to advance our AI strategy to significantly enhance resource efficiency, streamlining product development processes, and… more
- BD (Becton, Dickinson and Company) (Sparks, MD)
- …of innovative diagnostic solutions. We are seeking a visionary and experienced Director of Software Test to lead our global software testing organization. This ... responsible for developing and implementing a comprehensive software testing strategy that incorporates agile best practices, enterprise-level tools, and effective… more
- Takeda Pharmaceuticals (Boston, MA)
- …company that will inspire you and empower you to shine? Join us as a Director , Global Program Management in our Cambridge office. At Takeda, we are transforming the ... of this role will be to drive efficient and effective CDx strategy execution for early- and late-stage Oncology programs. Key responsibilities include development… more
- Bio-Techne (Minneapolis, MN)
- …worldwide.** Pay Range: $153,300.00 - $251,850.00 **Position Summary:** The Director of Manufacturing is responsible for overseeing and optimizing manufacturing ... operations for reagents at our Minneapolis headquarters. The Minneapolis...(ISO 9001, ISO 13485). + Collaborate with leadership on strategy , infrastructure planning, and organizational priorities. **What** **We're** **Looking… more
- Danaher Corporation (West Sacramento, CA)
- …the Danaher Business System which makes everything possible. The Senior Director , Marketing and Product Management - Microbiology for Beckman Coulter Diagnostics ... and want to work to build a world-class global operations organization-read on. In this role, you will have...will have the opportunity to: + Lead Product Portfolio Strategy & Lifecycle Management: Drive product portfolio planning, develop… more
- BD (Becton, Dickinson and Company) (San Diego, CA)
- …(Engineering, Science, Math/Stat) + Minimum 10 years experience in Quality, Regulatory, or Operations of a Medical Device, IVD , Pharmaceutical or Biotech firm. + ... **Job Description Summary** The Associate Director , Quality Systems & Architecture will be responsible...Systems & Architecture will be responsible for leading QMS strategy , including the developing, establishment and maintenance of QMS… more
- AbbVie (North Chicago, IL)
- …quality systems, regulatory affairs, medical writing, clinical development, clinical operations , manufacturing, epidemiology, marketing and other functional areas to ... Medical Device Safety Physician is independently responsible for proactive safety strategy , medical safety assessment of SAE/AEs reported to Product Surveillance,… more
- Bristol Myers Squibb (Princeton, NJ)
- …Read more: careers.bms.com/working-with-us . **Manager II, Lab Planning & Operations ** **Department** : Precision Medicine, Bioanalysis & Translational Sciences ... (PMBATS) **Location** : Lawrenceville, NJ **Reports To** : Director , Lab Planning & Execution **Summary / Scope** At...lives through science. The Manager II, Lab Planning & Operations will provide leadership and operational oversight for companion… more
- Evident Scientific (Needham, MA)
- …program leader and a regulatory compliance focal point for US operations , supporting submissions, inspections, and QMS compliance activities. Reporting to the ... Global Director of Regulatory Affairs - Clinical Business, the incumbent...Collaboration** + Lead coordination between Clinical Affairs, US regulatory operations , and Global RA teams to ensure consistent regulatory… more