• Senior Compliance Engineer

    J&J Family of Companies (Santa Clara, CA)
    …ISO 14971 processes. + Stay current with **global regulatory changes** (EU MDR, FDA , China NMPA, etc.) impacting EMC and safety compliance and communicate updates to ... **cybersecurity implications** for connected medical devices. + Working knowledge of ** FDA 510(k)** and **EU MDR Technical File** processes. **Core Competencies:** +… more
    J&J Family of Companies (01/06/26)
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  • Quality Control Inspector

    Aerotek (Lewisville, TX)
    …of subassemblies and finished products. This role involves ensuring compliance with FDA and ISO requirements and adhering to safety and corporate policies. The ... you'll be integral in supporting audits and submitting documentation for the FDA . **Responsibilities** + Perform receiving inspection on incoming materials based on… more
    Aerotek (01/06/26)
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  • Sr Regulatory Affairs Spec - Neuromod

    Medtronic (Minneapolis, MN)
    …resolve potential regulatory issues and questions from regulatory agencies. + Prepare FDA , European, and Canadian submissions for product changes to ensure timely ... teams for regulatory issues and questions. + Interact directly with FDA and international regulatory agencies on most projects/products at reviewer level,… more
    Medtronic (01/06/26)
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  • Data Reviewer, QC, US Site (Hopewell, NJ)

    BeOne Medicines (Pennington, NJ)
    …testing and release of materials, intermediates, and finished products under FDA /EU regulations and applicable international regulations. This role is essential for ... and release of materials, intermediates, and finished products, adhering to FDA /EU regulations and other applicable international standards. **Essential Functions of… more
    BeOne Medicines (01/06/26)
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  • Associate Director, BI&T Design and Optimization

    Bristol Myers Squibb (Manati, PR)
    …etc.) assuring compliance with Federal and Local Regulatory Agencies (eg OSHA, EPA, FDA , DEA, etc.) + Participates in regulatory audits as SME and assure areas ... with cGMP's, plan procedures, corporate procedures, and applicable regulations ( FDA , EMEA, DEA, etc.) of direct reports to maintain...+ TCP/IP Network Application + Thorough knowledge of cGMP, FDA and EMEA regulations are a must. + Excellent… more
    Bristol Myers Squibb (01/06/26)
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  • Director US Regulatory Strategy

    Lundbeck (Deerfield, IL)
    …creation of documentation to support investigational and marketing registration packages for the US FDA . + Liaises with FDA as needed for all aspects pertaining ... + Demonstrated and successful experience with face to face, hybrid, and/or virtual FDA interactions. + Ability to lead and work in cross-functional, matrixed, hybrid… more
    Lundbeck (01/05/26)
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  • Manufacturing Lead Technician - (Albumin Filling)

    Grifols Shared Services North America, Inc (Los Angeles, CA)
    …plasma derived pharmaceuticals. + Strict adherence to procedures and practices according to FDA regulations. + Strong emphasis on documentation according to FDA ... + Minimum of 3 years of related experience in a pharmaceutical, GMP, or FDA regulated environment is required. + Demonstrated leadership skills with the ability to… more
    Grifols Shared Services North America, Inc (01/02/26)
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  • Clinical Research Coordinator A/B

    University of Pennsylvania (Philadelphia, PA)
    …and data entry + Coordinate IRB submissions and renewals in accordance with FDA and IRB guidelines + Assure compliance with the protocol and regulatory requirements ... the conduct of study audits by sponsors, CRO's, the FDA and other entities as required. + Participate in...the conduct of study audits by sponsors, CRO's, the FDA and other entities as required. + Schedule patient… more
    University of Pennsylvania (01/02/26)
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  • CAPA / Quality Events Analyst (Hybrid)

    Caris Life Sciences (Phoenix, AZ)
    …across laboratory, operational, and customer-facing functions to maintain compliance with FDA , ISO 13485, CAP, and CLIA standards while driving proactive ... in alignment with Caris' Quality System procedures and applicable external requirements ( FDA 21 CFR, ISO 13485, CAP/CLIA, PMDA, CMDCAS, and other global regulatory… more
    Caris Life Sciences (12/31/25)
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  • Capgemini Invent - LS Reg Affairs & Qlty - Sr…

    Capgemini (New York, NY)
    …SEND awareness) and dataset remediation. + **Inspection Preparedness** : FDA /EMA mock inspections, audit readiness, corrective/preventive actions. + **Health ... , dossiers, and briefing packages with strategic input for FDA /EMA interactions. + Run **CDISC validation** (eg, Pinnacle 21)...+ Expertise in **eCTD** , **CTD Modules 2-5** , FDA guidance, and health authority expectations. + Proficiency with… more
    Capgemini (12/30/25)
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