- Philips (Malvern, PA)
- 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
- Philips (Hamilton, NJ)
- 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
- West Pharmaceutical Services (Exton, PA)
- …support submissions including Premarket Notifications, Technical Documentations under EU MDR (Medical Device Regulation), and Master Files (DMF/MAF) associated with ... pharmaceutical partner 's NDAs (New Drug Applications), ANDAs (abbreviated new drug...state-of-art standards/regulations. + Collaborate with regulatory lead(s), cross-functional project manager (s) and SMEs (Subject Matter Experts) in R&D, quality… more