- Globus Medical, Inc. (Audubon, PA)
- …prototyping, development testing, design verification and validation, manufacturing, FDA approvals, product introduction and post introduction monitoring. The ... product development . Creates and maintains project plans and FDA complaint Design history Files (DHF) for each project...Assists in the writing of regulatory applications to the FDA and other regulatory bodies . Partners with the… more
- Globus Medical, Inc. (Audubon, PA)
- …prototyping, development testing, design verification and validation, manufacturing, FDA approvals, product introduction and post introduction monitoring. The ... product development + Creates and maintains project plans and FDA complaint Design history Files (DHF) for each project...Assists in the writing of regulatory applications to the FDA and other regulatory bodies + Partners with the… more
- University of Pennsylvania (Philadelphia, PA)
- …all initial oversight submissions for regulatory documentation through the IRB, FDA and all applicable institutional regulatory review committees. In collaboration ... for NIH, pharmaceutical companies, contract research organizations (CROs), and the FDA , as well as, organize and maintain all regulatory affairs documentation/files… more
- University of Pennsylvania (Philadelphia, PA)
- …prepare and process all regulatory documentation through the IRB, CTSRMC, FDA and all applicable regulatory review committees- including new submissions, continuing ... pharmaceutical companies, contract research organizations (CROs), the NCI and the FDA , as well as, organize and maintain all regulatory affairs documentation/files… more
- Sumitomo Pharma (Harrisburg, PA)
- …relevant external advertising & promotional regulations or codes of practice (eg, FDA regulations, PhRMA guidelines, etc.) and are consistent with company guiding ... with the Office of Prescription Drug Promotion (OPDP) at FDA . + Serve as internal regulatory expert on ...FDA . + Serve as internal regulatory expert on FDA regulations, guidance and enforcement trends governing the promotion… more
- PCI Pharma Services (Philadelphia, PA)
- …to identify patterns requiring systemic solutions + Ensure compliance with FDA regulations, ISO 13485, Medical Device Directive, and other applicable standards ... understood and implemented + Support and participate in external audits including FDA , customers, and corporate audits **Team Development and Management** + Build,… more
- Aerotek (Bethlehem, PA)
- …and ensuring products are properly stored. You will be working with FDA -regulated products where quality is paramount, requiring attention to detail and adherence ... warehouse. + Maintain attention to detail, especially when dealing with FDA -regulated products. + Identify and correct mistakes promptly, ensuring compliance with… more
- United Therapeutics (Harrisburg, PA)
- …their daughter's pulmonary arterial hypertension (PAH). Today, we have six FDA -approved therapies that treat PAH, pulmonary hypertension associated with interstitial ... + Maintain deep understanding of external patient related guidance documents including FDA guidance on patient focused drug development (PFDD) and patient preference… more
- Merck (North Wales, PA)
- …across all documentation. + Interact independently with regulatory agencies ( FDA , EMA, etc.), including leading meetings, teleconferences, and written ... leading or supporting direct interactions with major Health Authorities (eg, FDA , EMA). + Demonstrated expertise in leading regulatory filings across global… more
- ThermoFisher Scientific (Pittsburgh, PA)
- …to GSG business including 21CFR820, 21CFR803, ISO 9001, ISO 13485, IVDR, cGMP's, FDA Guidelines, USP, and GxP. + Detailed knowledge of medical device manufacturing ... processes and experience with risk management regulations and standards, including FDA 21 CFR 820, MDSAP, IVDR, ISO 13485, and ISO 1497. + Detailed knowledge of… more
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