- Wolters Kluwer (Waltham, MA)
- The **Principal SaMD Technical Program Manager** plays a pivotal role in driving the development and delivery of Software as a Medical Device ( SaMD ) ... experience working on SaMD or regulated medical software products in technical program management, engineering, or project management roles using agile… more
- Takeda Pharmaceuticals (Lexington, MA)
- …compliance with international regulatory requirements and Takeda Global procedures. + Lead and develop a global organization, fostering talent, accountability, and ... products, in vitro diagnostics (IVDs), and Software as a Medical Device ( SaMD ) across all business units, geographies, and therapeutic modalities spanning Takeda's… more
- Sanofi Group (Cambridge, MA)
- …development. Proficiency inpreparingregulatorydocumentationwith standard submission processes. + ** Technical Knowledge:** Understanding of clinical development of ... **Job Title:** GRA Device Lead (Associate Director) - Digital Health **Location:** Cambridge,...the product lifecycle. Our department bridges the gap between technical development, manufacturing operations, and global regulatory authorities to… more