- Guthrie (Sayre, PA)
- …direct experience in clinical or pharmaceutical-sponsored research or regulatory fields such as the FDA , NIH, or HHS. + Minimum 5 years of experience in managing a ... Operations & Compliance + Deep understanding of human-subjects research compliance (AAHRPP, FDA , IRB, GCP, ICH). + Experience in integrating clinical research into… more
- Globus Medical, Inc. (Audubon, PA)
- …submissions, and approval for IDE/PMA submissions to the Food and Drug Administration ( FDA ) for class II and class III products. This position entails development of ... FDA submissions, requires working knowledge of products under review...in building working relationships with internal teams while following FDA 21 CFR regulationss. **Essential Functions** **:** + Partners… more
- Organon & Co. (Plymouth Meeting, PA)
- …time to approval by regulatory agencies, including but not limited to US- FDA or EU procedures (centralized, mutual recognition, decentralized) + Independently manage ... Represent our company with external organizations through direct communication with the FDA , EMA, or other EU regulatory agencies, including telephone calls and… more
- IQVIA (Wayne, PA)
- …expert in both the guidance and the practice of developing strategies to engage US FDA , the EMA and other regulatory agencies on COA endpoints and the use of Patient ... development of IQVIA's responses to public consultation processes from FDA and other regulatory agencies relating to PED +...regulatory practices, expectations and engagements outside of the US FDA and EMA In addition, take on other leadership… more
- Globus Medical, Inc. (Audubon, PA)
- …submissions, and approval for IDE/PMA submissions to the Food and Drug Administration ( FDA ) for class II and class III products. This position entails development of ... FDA submissions, requires working knowledge of products under review...in building working relationships with internal teams while following FDA 21 CFR regulations. **Essential Functions:** + Partners with… more
- Olympus Corporation of the Americas (Center Valley, PA)
- …and literature reviews). The Analyst III requires a thorough understanding of FDA regulatory requirements for complaint handling and MDR reporting per ISO13485, ... as requested. The ability to maintain quality documents to ensure compliance with FDA regulations and guidance documents relating to these areas of responsibility is… more
- ZOLL Medical Corporation (Pittsburgh, PA)
- …Super Saturated Oxygen (SSO2) Therapy is the first FDA -approved therapy since the stent 20+ years ago to ... softwareEssential Functions + Performs internal quality audits and effectiveness reviews ( FDA 's QSR, ISO 13485, MDD, CMDR) Conducts supplier evaluations and audits… more
- University of Pennsylvania (Philadelphia, PA)
- …with all policies relating to the University of Pennsylvania, Penn Medicine, FDA , GCP and other regulatory standards. The Clinical Research Coordinator (CRC) is ... the conduct of audits by study sponsors, CROs, the FDA , and other entities as required. + Process and...+ Adhere to all University of Pennsylvania, ICF, and FDA guidelines. + Coordination and oversight on time to… more
- West Pharmaceutical Services (Exton, PA)
- …ensuring compliance with quality system documents, cGMPs, ISO standards, and FDA regulations. **Education** + Bachelor's Degree and/or Masters in Science Technology ... device industry + Expertise of cGMP requirements, ISO standards and FDA regulations **Preferred Knowledge, Skills and Abilities** + Create multifaceted Laboratory… more
- University of Pennsylvania (Philadelphia, PA)
- …protocol compliance, and data quality. Adhere to all University of Pennsylvania, FDA and GCP guidelines. Job Description Clinical Research Coordinator BWith minimal ... participate in study team meetings, and follow all University of Pennsylvania, FDA , and GCP guidelines. Participation in study initiation, monitoring, audit, and… more