- Merck (West Point, PA)
- **Job Description** **Summary, Focus and Purpose** The Senior Engineer in Device Technology is a key member of our Device Development & Technology Team, with ... and combination products globally. * Experience in design controls, device risk management, medical device , complex combination...manner are at the core of this position. The Senior Engineer will routinely face competing priorities, and must… more
- West Pharmaceutical Services (Exton, PA)
- Senior Specialist , Regulatory Affairs - Medical Device Requisition ID: 69746 Date: May 13, 2025 Location: Exton, Pennsylvania, US Department: Regulatory ... including Premarket Notifications and Technical Documentation for CE Marking. The Senior Specialist ensures timely and high-quality execution of all… more
- West Pharmaceutical Services (Exton, PA)
- Sr . Specialist , Regulatory Affairs, Product Stewardship Requisition ID: 69466 Date: May 20, 2025 Location: Exton, Pennsylvania, US Department: Regulatory Affairs ... environment and planet through our sustainability efforts. **Job Summary** The Sr . Specialist , Regulatory Affairs evaluates supplier regulatory declarations for… more
- Globus Medical, Inc. (Audubon, PA)
- …can resume their lives as quickly as possible. **Position Summary** **:** The Senior Regulatory Affairs Specialist drafts, submits and gains clearance for 510(k) ... and approval for IDE/PMA submissions to the Food and Drug Administration (FDA) for class II and class III...+ 5+ years of related experience in the medical device industry + Understanding of regulatory requirements throughout the… more
- St. Luke's University Health Network (Bethlehem, PA)
- …providers, and infusion centers to monitor chemotherapeutic utilization, supportive drug therapy utilization, adverse drug reactions, therapeutic regimens, ... treatment of malignancy, safe handling of hazardous medication, and drug utilization. Mentors pharmacists, pharmacy residents, and students. Interacts with… more
- Fujifilm (Harrisburg, PA)
- …other duties as assigned. + Comply with all applicable US Food and Drug Administration (US FDA) medical device regulatory requirements, applicable ISO 13485 ... **Position Overview** The Sales Specialist , Diagnostic Oncology, in the Invitro Diagnostics Division,...Biomarkers sales through that community. As assigned interface with Senior Management teams from major IVD manufacturers. Maintain a… more
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