- Takeda Pharmaceuticals (Lexington, MA)
- …functions + Coordinate interdepartmental initiatives to optimize device clinical development timelines **Process Innovation:** + Lead initiatives to improve ... Development (DCD) in the Drug Product and Device Development (DPDD) group provides strategic clinical...+ Lead , mentor, and develop organization on device clinical development best practices, strategies, and… more
- Sanofi Group (Cambridge, MA)
- …exchange and peer-to-peer learning opportunities at congress venues. **HCP, Patient and Device Marketing** + Lead development of patient-directed materials ... Cambridge, MA **About the Job** The **Director, Global Marketing Qfitlia,** will lead the global _Stakeholder Engagement and Education Strategy_ to support the… more
- Sanofi Group (Cambridge, MA)
- **Job Title:** GRA Device Lead (Associate Director) - Digital Health **Location:** Cambridge, MA/ Morristown, NJ **About the Job** GRA Device Lead ... & Supply, Regulatory Health Authorities, and others. As GRA Device Lead in the GRA Device...environment and updating of standards and processes related to device regulations. + Contributes to the development … more
- Takeda Pharmaceuticals (Lexington, MA)
- …comply with medical device and combination device regulations. + Lead project execution activities and oversee the development of statistically sound ... feasibility, development , qualification and launch phases of device development . Area of focus will include...recommendations to move projects forward. + Identify, communicate and lead device design control process evolution to… more
- Takeda Pharmaceuticals (Lexington, MA)
- …and continuous improvement of operations and quality systems for medical device and digital health technologies, ensuring compliance with international regulatory ... requirements and Takeda Global procedures. + Lead and develop a global organization, fostering talent, accountability,...in vitro diagnostics (IVDs), and Software as a Medical Device (SaMD) across all business units, geographies, and therapeutic… more
- Sanofi Group (Cambridge, MA)
- …IVDselements + Contribute to device Health Authority interactions plan, lead device related health authority interactions and support cross-functional health ... race is on to speed up drug discovery and development to find answers for patients and their families....to get started? **Main Responsibilities** + Partner with the Device Regulatory Lead on assigned projects +… more
- Takeda Pharmaceuticals (Boston, MA)
- …+ Lead the following activities: + Combination products and device manufacturing process characterization. + Technology transfer to both CMOs or internal ... device manufacturing, with experience leading innovation initiatives. + Lead cross-functional teams and effectively influence key stakeholders-including Pharmaceutical… more
- Oracle (Boston, MA)
- …to user needs and validation meets usability and human factors standards. . Lead change management oversight across device -relevant business areas (internal and ... up a specialized clinical product management team focused on medical device -aligned products. This team bridges clinical practice, product strategy, and regulatory… more
- Oracle (Boston, MA)
- …to user needs and validation meets usability and human factors standards. . Lead change management oversight across device -relevant business areas (internal and ... up a specialized clinical product management team focused on medical device -aligned products. This team bridges clinical practice, product strategy, and regulatory… more
- ICS (Waltham, MA)
- …are seeking a seasoned Senior Project Manager with extensive experience in the medical device software development sector. In this critical role, you will be ... Senior Project Manager - Medical Device Software Waltham, MA Apply Now Senior Project...Orders to manage scope effectively. + Agile & Team Leadership: Lead Agile/Scrum ceremonies, including daily stand-ups and sprint reviews.… more