- 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)
- …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
- 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