- Terumo Medical Corporation (Somerset, NJ)
- …and scientific support for the organization that includes Medical Affairs , Clinical Operations, Sales, Marketing, Regulatory Affairs , to ensure maximum ... and external stakeholders. + Build relationships and demonstrate the clinical outcome and benefits of company products to Key...+ Regulatory activities partnership: + Work with regulatory affairs to ensure that all written… more
- Olympus Corporation of the Americas (Center Valley, PA)
- …papers, and literature reviews). The Analyst III requires a thorough understanding of FDA regulatory requirements for complaint handling and MDR reporting per ... team member/ leader, in fulfilment of corporate objectives for FDA regulatory compliance. Performs routine assignments independently;...Notes: || United States (US) || Pennsylvania (US-PA) || Center Valley || Quality & Regulatory Affairs … more
- Terumo Medical Corporation (Somerset, NJ)
- …cross-functionally, will collaborate with internal stakeholders, to include Clinical Affairs , Professional & Clinical Education, Regulatory Affairs ... Marketing, Sales as well as external stakeholders, to include FDA , NB, PMDA, KOL, HCP, IRB and publishers. The...reports, documents and scientific presentations in cooperation with the Clinical , Medical, & Regulatory Affairs … more
- Olympus Corporation of the Americas (Center Valley, PA)
- …areas. + Execute global internal audit activities for the Quality Assurance and Regulatory Affairs Function and tracks and coordinates audit corrective actions ... + Coordinates and leads audit activities with all global regulatory agencies (eg FDA , Notified Bodies, PMDA,...Notes: || United States (US) || Pennsylvania (US-PA) || Center Valley || Quality & Regulatory Affairs … more
- Cordis (Irvine, CA)
- …Accountabilities** + Collaborate with cross-functional teams, including product management, regulatory affairs , quality assurance, and manufacturing, to define ... + Knowledge of medical device design principles, human factors engineering, and regulatory requirements (ISO 13485, FDA guidelines, etc.). + Proficiency in… more
- Stony Brook University (Stony Brook, NY)
- …with both academic and industry collaborators and to gain experience communicating with regulatory authorities such as the FDA . This position requires a recent ... will also participate in ongoing radiochemistry procedures for current clinical research studies, including production, quality control and metabolite analysis.… more
- BeOne Medicines (San Mateo, CA)
- …leading or working with centralized teams for Statistical Programming. + Experience in FDA /EMEA/CFDA trial and regulatory submissions. + Experience with the drug ... collaborate with cross-functional teams, including biostatistics, epidemiology, and medical affairs to design, implement, and deliver high-quality analytic datasets,… more
- Terumo Medical Corporation (Elkton, MD)
- …to work effectively in cross-functional teams including R&D, Quality, Manufacturing, and Regulatory Affairs . + Strong organizational skills to meet deadlines and ... products, training and education programs that drive clear economic value, better clinical outcomes and improved quality of life for patients. TMC is part… more
- RWJBarnabas Health (West Orange, NJ)
- …NJ + Minimum of 8 years of legal experience, including substantial experience with clinical research, FDA regulatory compliance, and research contracting + ... Senior Counsel, Assistant Vice President of Legal Affairs , Clinical Research & Regulatory...and multi-site trial oversight + Counsel stakeholders on Good Clinical Practice, FDA inspection readiness, and compliance… more
- Regeneron Pharmaceuticals (Sleepy Hollow, NY)
- …a typical day might include:** The Manager position within the Regulatory Affairs department requires the ability to apply clinical development knowledge in ... typically carrying out the responsibilities with guidance from the Regulatory Affairs , Advertising and Promotion Director. The...Help lead and assist in all interactions with the FDA Office of Prescription drug Promotion (OPDP) for assigned… more
