• Regulatory Affairs Specialist

    Teleflex (Morrisville, NC)
    …to launch for moderate-complexity projects and ensure appropriate data collection for regulatory submissions and compliance . * Review and assess change control ... activities for potential impact on current regulatory filings. * Ensures compliance with design...audits to mitigate any potential risks. * Interface with FDA , Notified Bodies, or other national health agencies regarding… more
    Teleflex (08/13/25)
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  • Regulatory Program Coordinator

    Saint Luke's (Kansas City, MO)
    …and coordinate all activities related to maintaining an ongoing state of regulatory compliance through proactive risk assessments and mitigation efforts. ... risk or deficiency. Oversee ongoing monitoring to ensure sustained regulatory compliance . + Manage all aspects of...Joint Commission, The Department of Health, OSHA, and the FDA . In this role, represent the hospital during surveys… more
    Saint Luke's (07/22/25)
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  • Senior Principal Regulatory Affairs…

    Bausch + Lomb (Madison, WI)
    …reporting, administrative documentation, due diligence, market expansion, labeling content, regulatory compliance , regulatory intelligence and change ... to product development teams and give guidance on potential regulatory compliance issues + Point of contact...opinion leaders, and advisory boards + Working knowledge of FDA regulations / Code of Federal Regulations (CFR) **We… more
    Bausch + Lomb (09/06/25)
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  • R&D Regulatory Manager

    Grifols Shared Services North America, Inc (Fort Worth, TX)
    …more than 110 countries and regions. **Summary:** Develops and implements worldwide regulatory programs for marketed products and/or those for development, and has ... interactions with regulatory authorities to expedite approvals. Participate in the development of, and leads/executes regulatory strategy and tactical decisions… more
    Grifols Shared Services North America, Inc (09/06/25)
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  • Regulatory Affairs Specialist,…

    Hologic (Louisville, CO)
    …product registrations. + Review labeling, marketing materials, and user manuals for compliance with US and international regulatory requirements. + Identify and ... storage systems). + Knowledge of ISO 13485, ISO 9001, FDA , and foreign (EU, Canada, etc.) regulatory ...global teams. + Proactive approach to identifying and resolving compliance issues. + Commitment to continuous learning and professional… more
    Hologic (09/04/25)
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  • Post-Doctoral Regulatory Affairs Fellow…

    Boehringer Ingelheim (Ridgefield, CT)
    …from various partners. + Handle the development of custom reports to support regulatory compliance and advise strategy. + Collaborate with partners to support ... any compliance and process initiatives. + Own the review and refinement of regulatory FDA guidance and recommendations by developing written comments… more
    Boehringer Ingelheim (08/30/25)
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  • Clinical Research Regulatory Affairs…

    University of Pennsylvania (Philadelphia, PA)
    …of study specific case report forms, as well as, to provide direct regulatory / compliance guidance. + Perform additional regulatory duties as assigned. ... programs and resources, and much more. Posted Job Title Clinical Research Regulatory Affairs Specialist Job Profile Title Clinical Research Regulatory Specialist… more
    University of Pennsylvania (08/27/25)
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  • Director of Quality and Regulatory Affairs

    Kelly Services (Anaheim, CA)
    …products. You will also serve as the Management Representative and Person Responsible for Regulatory Compliance under 21 CFR Part 111 and 117, while providing ... complete manufacturing and QA/QC process to ensure conformance and compliance and manage the Quality System in accordance with...USA and global regulations. + Proven experience interfacing with regulatory bodies such as FDA , Notified Bodies,… more
    Kelly Services (08/21/25)
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  • Regulatory Affairs Intern - Miami, Florida

    Danaher Corporation (Miami, FL)
    …The Regulatory Affairs Intern will gain hands-on experienc e in regulatory strategy, documentation, and compliance within the life sciences industry. You'll ... or coursework in regulatory affairs or quality assurance . Understanding of FDA , EMA, or ICH guidelines . Proficiency in Microsoft Office Suite (Word, Excel,… more
    Danaher Corporation (08/16/25)
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  • Senior Manager, Regulatory Affairs,…

    BeOne Medicines (San Mateo, CA)
    …and other business functions in the United States and Canada to ensure compliance with applicable regulatory requirements and guidelines, and consistency with ... procedures, as necessary. + Maintains up to date information regarding initiatives by FDA , Health Canada, and other applicable regulatory authorities related to… more
    BeOne Medicines (08/14/25)
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