- 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
- Oracle (Boston, MA)
- …safety, risk management, usability, security, and post-market surveillance. **Key Responsibilities** ** SaMD Program Leadership** + Lead end-to-end planning ... , and related IMDRF SaMD principles. + 5+ years of technical program management experience, including leading complex engineering programs in regulated… 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
- Takeda Pharmaceuticals (Lexington, MA)
- …true to the best of my knowledge. **Job Description** **OBJECTIVES / PURPOSE** The SaMD and IVD Principal Manager is an experienced quality and technical ... within the Device Quality (DQ) function to support software medical devices ( SaMD ), in vitro diagnostics (IVD), and combination products across all phases of… 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