- Philips (Cambridge, MA)
- The Senior Regulatory Affairs Program Manager will play a critical role in ensuring Philips' Ambulatory Monitoring & Diagnostics (AM&D) products are compliant by ... procedures to ensure compliance with US CFR, ISO 13485, MDD/ MDR , CMDR, MDSAP and all other applicable regulations and...including spouses and other family members, marital or domestic partner status, or any other category protected by federal,… more
- Takeda Pharmaceuticals (Cambridge, MA)
- …Transfer Agreement and other specifications provided by Data Engineer + Partner closely with internal/external stakeholders and data engineers in a collaborative ... + Bachelor's degree plus minimum of 7+ years' experience (Sr. Manager )in computer science, statistics, biostatistics, mathematics, biology or other health related… more
- Philips (Cambridge, MA)
- The Senior Manager Regulatory Affairs will play a critical role within Philips' Clinical Informatics organization by leading regulatory projects for Philips' Disease ... market on time. + You have detailed knowledge of MDD/ MDR , MedDev's, FDA QSR's, FDA SaMD related and cybersecurity...including spouses and other family members, marital or domestic partner status, or any other category protected by federal,… more
- ZOLL Medical Corporation (Chelmsford, MA)
- …Demonstrated experience working in a product development capacity as a matrixed, cross-disciplinary partner (ie, as a project manager /core team leader and core ... + Experience with successful regulatory filings for global medical devices (minimally, FDA 510K and MDR CE Mark; ideally FDA PMA and other global authorities) +… more