• Senior Manager , Regulatory

    Sumitomo Pharma (Austin, TX)
    …a dynamic, highly motivated, and experienced individual for the position of Senior Manager , Regulatory Operations, For assigned projects, the Senior Manager ... Manages the planning, tracking, compiling, quality checking and submission of required FDA Submissions (eg Establishment Registrations, Drug Product Listings). +… more
    Sumitomo Pharma (07/18/25)
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  • Sr Product Development Engineer Safety…

    FREEMAN (Dallas, TX)
    …The ideal candidate will have a strong background in engineering, safety, and regulatory compliance. You will lead the product management structures team and ... + Testing and Validation: Develop and execute testing plans to validate product performance, safety, and regulatory compliance. + Documentation: Maintain… more
    FREEMAN (06/28/25)
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  • R&D Regulatory Manager

    Grifols Shared Services North America, Inc (Fort Worth, TX)
    …and initiatives that significantly impact the business. + Advises Management on regulatory aspects of product development and/or lifecycle management. Identifies ... more than 110 countries and regions. **Summary:** Develops and implements worldwide regulatory programs for marketed products and/or those for development, and has… more
    Grifols Shared Services North America, Inc (07/29/25)
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  • Lead Technology Product Manager

    Wolters Kluwer (Coppell, TX)
    **Lead Technology Product Manager ** - Commercial Drug Information This role follows a hybrid model, offering the flexibility to work remotely while staying ... **SUMMARY** As part of the **Wolters Kluwer Health team** , the **Lead Technology Product Manager for Medi-Span** plays a critical role in advancing our… more
    Wolters Kluwer (07/18/25)
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  • Sr Manager , Technical Services…

    Abbott (Plano, TX)
    …interventional pain therapy to patients throughout the pain continuum. As the Sr Manager , Technical Services & Product Performance Group you will manage the ... complex regulatory problems and issues. Ensures employee compliance with product division policies, procedures and practices. **What You'll Work On** +… more
    Abbott (07/26/25)
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  • Center Manager

    Kedplasma (El Paso, TX)
    …with KEDPLASMA SOPs and other company standards and protocols to meet the regulatory requirements of the FDA , EMEA, Customer Specifications, and other ... present to cover hours of operation in adherence to regulatory requirements and to minimize donor wait times during...protocols and maintains IQPP Viral Marker Standards. + Ensures FDA licensed product ; SISPQ (strength, identity, safety,… more
    Kedplasma (07/26/25)
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  • Assistant Manager

    Kedplasma (Dallas, TX)
    …with KEDPLASMA SOPs and other company standards and protocols to meet the regulatory requirements of the FDA , EMEA, Customer Specifications, and other ... may have! **JOB SUMMARY** Assists and supports the Center Manager in the daily operations of a plasma collection...within the scope of EU Good Practice Guidelines and FDA cGMP 21CFR. **ESSENTIAL JOB FUNCTIONS** Every effort has… more
    Kedplasma (07/26/25)
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  • Senior Manager , Clinical Quality…

    Danaher Corporation (Austin, TX)
    …related to Good Clinical Practice with hands on experience in dealing directly with FDA and other regulatory agencies + Proven track record of managing ... Business System (https://www.danaher.com/how-we-work/danaher-business-system) which makes everything possible. The Senior Manager , Clinical Quality and Compliance reporting to the Senior… more
    Danaher Corporation (07/25/25)
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  • QA Manager

    Kedplasma (Houston, TX)
    …ensures corrective action(s) as needed. . Responsible, in collaboration with the Center Manager , for overseeing all activities related to product quality, and ... DCOP's and other Company standards and protocols to meet regulatory requirements of the FDA , EMEA, Customer...and meeting(s) in a timely manner as instructed by supervisor/ manager . . Cooperate with department personnel, as well as… more
    Kedplasma (07/26/25)
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  • QA Program Manager

    Fujifilm (College Station, TX)
    …of program quality activities per approved Quality Agreements, and ensure compliance with FDA , EU, and other relevant regulatory bodies. + Work with functional ... routine tasks and general directions only for new assignments. + Familiarity with regulatory standards, including cGMP, FDA , EU, and risk management practices. +… more
    Fujifilm (06/11/25)
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