- 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 ) ... Collaboration and leadership are central to this role. The Principal SaMD TPM acts as a bridge... SaMD or regulated medical software products in technical program management, engineering, or project management… more
- Oracle (Boston, MA)
- …, and related IMDRF SaMD principles. + 5+ years of technical program management experience, including leading complex engineering programs in regulated ... safety, risk management, usability, security, and post-market surveillance. **Key Responsibilities** ** SaMD Program Leadership** + Lead end-to-end planning and… more
- Oracle (Boston, MA)
- …Over the next year, HDI must execute a large volume of ** technical documentation, risk management activities, and engineering design updates** required for ... health platform. To support these efforts, we are hiring **Regulatory Technical Documentation Engineers** with **deep engineering backgrounds** , strong technical… more
- Philips (Cambridge, MA)
- The Principal Regulatory Affairs Specialist will develop and execute the regulatory strategy for new product development, design changes, and field safety ... a primary focus on Software as a Medical Device ( SaMD ) for our Sleep & Respiratory Care products in...compliance in internal processes, work instructions, and forms. Apply technical expertise to process improvement efforts. **You're the right… more
- Medtronic (Boston, MA)
- …be assigned. + Must have experience, subject matter expertise (SME), and technical knowledge working with regulated medical device software and product cybersecurity ... development of training and awareness programs for Software as a Medical Device ( SaMD ), Software in a Medical Device (SiMD), and product cybersecurity designed to… more