- Wolters Kluwer (Chicago, IL)
- 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 (Annapolis, MD)
- …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
- J&J Family of Companies (Warsaw, IN)
- …to understand the project scope to drive product improvements and efficiently generate technical documentation. In this role, you will lead and execute various ... + Use standard methodologies for building Software as a Medical Device ( SaMD ) technology under Design Control procedures. + Translate requirements into application… more
- Medtronic (San Diego, CA)
- …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, ... to validate the value proposition of Medtronic AI platforms + Initiate and lead engagements with internal cross-functional leaders to accelerate and close the sales… more
- AbbVie (Mettawa, IL)
- …Owner for the PACE framework - an omnichannel automation of patient interactions. Lead the program from discovery through execution, developing its blueprint, ... AbbVie is seeking a strategic and experienced Senior Manager to lead patient-facing digital initiatives for our international Affiliates, including myAbbVieCare… 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