- University of Pennsylvania (Philadelphia, PA)
- …This position requires significant dedication and resilience to acquire and apply regulatory knowledge with the duty to protect research patient safety and data ... all times. Develop working knowledge of and apply relevant national and international principles of human subject protections and privacy throughout all clinical… more
- University of Pennsylvania (Philadelphia, PA)
- …breast cancer". The SHIP Trial seeks to collect research evidence to inform regulatory approvals for HPV testing by self-collection for cervical cancer screening in ... their associated instructions for use (IFU) and specimen processing steps submitted for regulatory review to the US Food and Drug Administration (FDA) by various… more
- University of Pennsylvania (Philadelphia, PA)
- …recruitment, data management, subject visits, follow-up activities, and maintaining rigorous regulatory documentation. The CRC will be integral to the smooth ... monitoring, internal and external auditing, and study close-out visits. Interface with regulatory authorities, Sponsors and cooperative groups as directed by the CSU… more
- University of Pennsylvania (Philadelphia, PA)
- …well as completion of study related activities including but not limited to regulatory submissions, data entry, and regulatory compliance visits. + Assure ... compliance with the protocol and regulatory requirements includes collecting, recording, and maintaining data and...of the Title 21 Code of Federal Regulations (CFR), International Conference of Harmonisation (ICH) and Good Clinical (Research)… more
- Capgemini (Pittsburgh, PA)
- …devices where applicable. *Assists with complaint investigation and documentation interfaces with Regulatory Affairs to support UL, IEC, and FDA submissions. ... stage. *Support Design Control activities by ensuring compliance with FDA and international regulations. *Lead and participate in Design Failure Modes and Effects… more
- Williams Companies (Pittsburgh, PA)
- …Greenhouse Gas Emissions, Greenhouse Gas Management, Greenhouse Gas Reporting, US Regulatory Affairs Competency Requirements: Why Williams? Looking to apply ... in or handles the approved course of action, including required regulatory documentation + Participates in continuous improvement projects with the focus… more
- Grifols Shared Services North America, Inc (Williamsport, PA)
- …regulatory filings (IND, study reports, NDA, etc.) in cooperation with colleagues in Regulatory Affairs and other functions + Serve as program medical expert ... Would you like to join an international team working to improve the future of...+ Provide strategic input for clinical development plans and regulatory strategy + Provide input/review of clinical documents, eg… more
- J&J Family of Companies (Spring House, PA)
- …the TA (TA R&D, Clinical Development, DPDS) and partnering functions ( Regulatory , Global Development, Medical Affairs , Commercial). **Qualifications / ... to work in a global matrix environment with cross-functional, international teams * Ability to think dynamically, with a...Travel up to 10% of the time (domestic and international ), defined by business needs. **Preferred:** * Previous project… more
- Capgemini (Pittsburgh, PA)
- …where applicable. + Assist with complaint investigation and documentation interfaces with Regulatory Affairs to support UL, IEC, and FDA submissions. ... and support design control activities, ensuring compliance with FDA and international regulations. This role will involve coordinating design review meetings,… more
- Olympus Corporation of the Americas (Center Valley, PA)
- …by applicable federal, state or local law. Posting Notes: || United States (US) || Pennsylvania (US-PA) || Center Valley || Quality & Regulatory Affairs (QA/RA) ... Global nature of this role. + Some domestic and international travel. + Ability to influence across multiple sites....activities (desired). + Knowledge of Risk Management practices and regulatory requirements such as FDA QSRs, ISO 13485, ISO… more