- 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
- 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
- Medtronic (Boston, MA)
- …and innovation, while helping champion healthcare access and equity for all. You'll lead with purpose, breaking down barriers to innovation in a more connected, ... + Must have experience, subject matter expertise (SME), and technical knowledge working with regulated medical device software and...and awareness programs for Software as a Medical Device ( SaMD ), Software in a Medical Device (SiMD), and product… more
- Olympus Corporation of the Americas (Westborough, MA)
- …to Agile SW development practices. This position provides subject matter expertise, technical guidance, and leadership for the application of health and medical ... ISO 81001-5-1, and AAMI TIR34971. This includes providing leadership, technical direction and collaboration on development strategies, concepts, design evaluation… more