- 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
- Sanofi Group (Morristown, NJ)
- …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 (Minneapolis, MN)
- …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
- Meta (New York, NY)
- …for medical devices intended for direct to consumer health wearables 14. Demonstrated lead in preparing a 510k or Technical Dossier **Public Compensation:** ... work on wearables and Software as a Medical Device ( SaMD ) applications for the US and worldwide approvals.You will...cybersecurity, ISO 13485, ISO 14971, IEC 62304, etc.) 12. Technical expertise in software development practices and how to… more
- Medtronic (Sacramento, 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
- Abbott (Santa Clara, CA)
- …within the Medical Devices Digital Solutions organization. In this role, you will lead the technical execution of Abbott's Medical Devices Digital (MDD) AI ... high employer contribution . Tuition reimbursement, the Freedom 2 Save student debt program and FreeU education benefit - an affordable and convenient path to… more
- Philips (Cambridge, MA)
- …Regulatory Affairs Organization, the Principal Regulatory Affairs Specialist will lead and provide regulatory oversight for critical new product development ... Medical Device/HealthTech product environments. Experience with Software as Medical Device ( SaMD ) and Ultrasound Imaging Devices highly desired. + You have strong… more