- Wolters Kluwer (New York, NY)
- 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
- 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
- Meta (New York, NY)
- …and the Design History File) for software as a medical device ( SaMD ) programs. **Required Skills:** Medical Devices, Design Assurance Engineer Responsibilities: 1. ... Lead and execute design control activities for medical device...regulatory compliance, especially for Software as a Medical Device ( SaMD ) platforms 4. Collaborate cross-functionally with engineering, regulatory, 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