- University of Pennsylvania (Philadelphia, PA)
- …be aware of agreements with outside parties to ensure appropriate Sponsor Oversight. The Regulatory Affairs Specialist C, prepares submissions to the FDA in ... be aware of agreements with outside parties to ensure appropriate Sponsor Oversight. The Regulatory Affairs Specialist C, prepares submissions to the FDA in… more
- West Pharmaceutical Services (Exton, PA)
- Sr. Specialist Regulatory Affairs, MD Requisition ID: 71773 Date: Nov 21, 2025 Location: Exton, PA, US Department: Regulatory Affairs Description: **This is ... environment and planet through our sustainability efforts. **Job Summary** The Regulatory Affairs Sr. Specialist is responsible for influencing department… more
- ThermoFisher Scientific (Pittsburgh, PA)
- …Senior Regulatory Affairs Specialist , you'll provide strategic guidance on regulatory pathways, manage submissions , and serve as a subject matter expert ... (FDA, EU MDR/IVDR, other international regulations)** **Experience preparing and managing regulatory submissions (510(k), PMA, CE marking, technical files)**… more
- Oracle (Harrisburg, PA)
- …and deficiencies. + Coordinates the preparation of and may prepare document packages for regulatory submissions from all areas of company as well as for internal ... regulatory agencies. **Responsibilities** + Performs evaluation of internal operations , controls, communications, risk assessments and maintenance of documentation… more
- University of Pennsylvania (Philadelphia, PA)
- …the Director in providing direction and strategic planning for clinical research regulatory operations including overseeing the activities of a Regulatory ... in providing direction and strategic planning for clinical research regulatory operations including overseeing the activities of...for Regulatory Affairs will have oversight of regulatory submissions to the IRB and all… more
- Eurofins US Network (Lancaster, PA)
- …Device Services has been assisting Medical Device companies developmental testing and regulatory submissions for over 45 years. With over 20 state-of-the-art ... Device capabilities, offering tailored solutions based on their specific product and regulatory strategy. + Manage the full sales cycle including working closely… more
- University of Pennsylvania (Philadelphia, PA)
- …highly collaborative research environment alongside a team of study coordinators, a regulatory specialist , project managers, investigators, and clinical staff to ... with protocol requirements; scheduling and conducting research visits in clinic; maintaining regulatory files; and preparing submissions to the Penn Biomedical… more