• Sr. Project Manager (Medical Devices, NPI…

    Philips (New Kensington, PA)
    …management, and issue resolution through robust tracking and reporting mechanisms. + Ensure regulatory compliance with FDA design controls and global ... teams, ensuring alignment with strategic business objectives. + Coordinate with Quality, Regulatory , R&D, Operations, and Marketing teams to meet goals related to… more
    Philips (08/14/25)
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  • Global MDR Submission Analyst III

    Olympus Corporation of the Americas (Center Valley, PA)
    …Functions as team member/ leader, in fulfilment of corporate objectives for FDA regulatory compliance . Performs routine assignments independently; supports ... reviews). The Analyst III requires a thorough understanding of FDA regulatory requirements for complaint handling and...requested. The ability to maintain quality documents to ensure compliance with FDA regulations and guidance documents… more
    Olympus Corporation of the Americas (06/19/25)
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  • Medical Liaison-Radiology

    CTG (Myerstown, PA)
    …in delivering training in-person, virtually, and in hybrid environments. + Knowledge of regulatory compliance and FDA guidance for dissemination of medical ... information. **Experience:** + Proven experience in clinical, medical affairs, or related roles within radiology or medical science liaison functions. + Experience with advisory boards, speaker training, and investigator-initiated research. + Demonstrated… more
    CTG (08/23/25)
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  • Director Regulatory Compliance

    Charles River Laboratories (Wayne, PA)
    …working relationship with site/operation management to assure a cohesive approach to regulatory compliance . ⦁ Assure staff receives appropriate regulatory ... River operations and serves as a member of the Regulatory Affairs and Compliance management team. Provides...drugs approved by the US Food and Drug Administration ( FDA ) in the past five years. We're committed to… more
    Charles River Laboratories (06/19/25)
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  • Associate Director, Global Regulatory…

    Organon & Co. (Plymouth Meeting, PA)
    …products, in order to optimize label and obtain shortest time to approval by regulatory agencies, including but not limited to US- FDA or EU procedures ... + Represent our company with external organizations through direct communication with the FDA , EMA, or other EU regulatory agencies, including telephone calls… more
    Organon & Co. (07/26/25)
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  • Senior Regulatory Specialist

    Globus Medical, Inc. (Audubon, PA)
    …needed for IDE and PMA reporting + Reviews Document Change Orders for Regulatory compliance , including drawings and labeling changes + Performs routine ... as quickly as possible. **Position Summary** **:** The Senior Regulatory Affairs Specialist drafts, submits and gains clearance for...for IDE/PMA submissions to the Food and Drug Administration ( FDA ) for class II and class III products. This… more
    Globus Medical, Inc. (06/25/25)
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  • Regulatory Specialist

    Globus Medical, Inc. (Audubon, PA)
    …needed for IDE and PMA reporting + Reviews Document Change Orders for Regulatory compliance , including drawings and labeling changes + Performs routine ... their lives as quickly as possible. **Position Summary:** The Regulatory Affairs Specialist assists with drafting, submitting and gaining...for IDE/PMA submissions to the Food and Drug Administration ( FDA ) for class II and class III products. This… more
    Globus Medical, Inc. (06/25/25)
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  • Senior Regulatory Affairs Specialist

    Philips (Reedsville, PA)
    …recommends process improvements, updates regulatory SOPs, and applies broad regulatory knowledge to support compliance across various geographies and ... Responsible for coordinating the planning, preparation, assembly, review and publication of regulatory submissions to the FDA , EU and other worldwide government… more
    Philips (08/29/25)
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  • Clinical Research Regulatory Specialist B…

    University of Pennsylvania (Philadelphia, PA)
    … Affairs Specialist-CC will, with minimal supervision, prepare and process all regulatory documentation through the IRB, CTSRMC, FDA and all applicable ... NCI and the FDA , as well as, organize and maintain all regulatory affairs documentation/files as required. The Regulatory Affairs Specialist-CC is expected… more
    University of Pennsylvania (08/03/25)
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  • Director, Regulatory Advertising…

    Sumitomo Pharma (Harrisburg, PA)
    …+ Establish a working relationship with the Office of Prescription Drug Promotion (OPDP) at FDA . + Serve as internal regulatory expert on FDA regulations, ... encounters is considered confidential. ** Compliance ** : Achieve and maintain Compliance with all applicable regulatory , legal and operational rules and… more
    Sumitomo Pharma (07/08/25)
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