- Olympus Corporation of the Americas (Center Valley, PA)
- …from manager ; requires general instruction for new or special assignments from Manager . The Global MDR Analyst II will maintain quality documents to ensure ... all the geographic locations you would consider. * Olympus is looking for Global MDR Submissions Analyst II. Hiring Location: US **Job Description** Global MDR … more
- Olympus Corporation of the Americas (Center Valley, PA)
- …all the geographic locations you would consider. * Olympus is looking for Global MDR Submissions Analyst III. Hiring Location: US **Job Description** As a Global ... MDR Submission Analyst III OSTA team member, you will...initiates new or special assignments with occasional direction from Manager . **Job Duties** + A seasoned, experienced professional with… more
- 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 (Pittsburgh, PA)
- We are seeking an entrepreneurial Project Manager to lead cross-functional teams in developing innovative electro-mechanical products for Philips Sleep & Respiratory ... + You've acquired 2+ years of experience as a technical project manager leading projects with substantial medical product development activities, preferred. You have… more
- Philips (Pittsburgh, PA)
- 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
- Philips (Pittsburgh, PA)
- **Global Supplier Accounts Manager - Devices & Accessories for AM&D** Your primary focus will be optimizing the supply base and reducing total cost of ownership ... Extensive experience in a production environment, preferably in Medical/FDA and/or EU- MDR regulated settings. + Demonstrated program management skills to drive… 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
- Olympus Corporation of the Americas (Center Valley, PA)
- …Surveillance Plans and Periodic Safety Update Reports + Knowledge of EU 2017/745 (EU MDR ), FDA QSR, ISO 13485 and other applicable industry standards + Travel up to ... safer and more fulfilling. As a global medical technology company, we partner with healthcare professionals to provide best-in-class solutions and services for early… more