- ThermoFisher Scientific (Pittsburgh, PA)
- …Standard (Mon-Fri) **Environmental Conditions** Office **Job Description** **Overview:** The Regulatory Affairs Specialist II is responsible for ensuring ... expert support on hazardous material shipping. + Support ongoing sales and regulatory operations for the CCG organization through additional project work as needed.… more
- ZOLL Medical Corporation (Pittsburgh, PA)
- …to build your career.Job SummaryDirects the activities of the Quality Assurance and Regulatory Affairs department. Ensures the quality and regulatory systems ... are effectively implemented and maintained.Essential Functions + Pre-market approval of new and modified medical devices in domestic and international markets. + Post-market surveillance and medical device reporting in domestic and international markets +… more
- Organon & Co. (Plymouth Meeting, PA)
- …questions per established business processes and systems. + Demonstrate an understanding of regulatory affairs and apply this understanding to the benefit of the ... Scientist (Associate Director) is responsible for developing and implementing Regulatory Chemistry, Manufacturing & Controls (CMC) strategies for assigned small… more
- Globus Medical, Inc. (Audubon, PA)
- …Recommends changes for labeling, manufacturing, marketing and clinical protocol for regulatory compliance. Monitors and improves tracking and control systems. Keeps ... abreast of regulatory procedures and changes. Recommends strategies for earliest possible...clinical trials applications. **Essential Functions** **:** + Demonstrates global regulatory expertise in product submissions and evaluates changes with… more
- University of Pennsylvania (Philadelphia, PA)
- …trials that offer cutting-edge oncology treatments. Contingent upon funding. The ACC OCCR Regulatory Affairs Office seeks a full-time Regulatory Affairs ... in the coordination of Phase I-V clinical trials. Reporting to the Regulatory Affairs Research Teams Manager, the Regulatory Affairs Specialist-CC… more
- Olympus Corporation of the Americas (Center Valley, PA)
- …applicable federal, state or local law. Posting Notes: || United States (US) || Pennsylvania (US-PA) || Center Valley || Quality & Regulatory Affairs (QA/ RA ) ... The Analyst III requires a thorough understanding of FDA regulatory requirements for complaint handling and MDR reporting per...tasks with other cross-functional team members and the local RA /QA representatives for countries outside of the US and… more
- Merck (North Wales, PA)
- …+ Coordinate regional regulatory strategy and submissions through collaboration with Regulatory Affairs Europe (RAE) and local affiliate teams. + Provide ... + Local registration study protocols for secondary markets + Represent Global Regulatory Affairs on internal committees (eg, DRC, ADT/PDT, EDT, LEAD) to provide… more
- University of Pennsylvania (Philadelphia, PA)
- …Temporary Employee - Non-Exempt Job Description Ophthalmology seeks a part-time Regulatory Affairs Start-Up Specialist-CC to facilitate, with minimal supervision ... (CROs), and the FDA, as well as, organize and maintain all regulatory affairs documentation/files as required. The Regulatory Affairs Start-Up… more
- Olympus Corporation of the Americas (Center Valley, PA)
- …applicable federal, state or local law. Posting Notes: || United States (US) || Pennsylvania (US-PA) || Center Valley || Quality & Regulatory Affairs (QA/ RA ) ... with other functions both within and outside of Quality, including Regulatory Affairs , Information Technology, Service, Repair, Manufacturing, Commercial teams… more
- University of Pennsylvania (Philadelphia, PA)
- …student workers, Resident advisors (RAs) and residential faculty; supporting RA selection-related activities and student worker hiring processes; facilitating ... periods. Assist with CHAS central administrative projects such as RA training and other programs. + Execute administrative projects...allows you to relax, take vacations, attend to personal affairs , recover from illness or injury, spend time with… more