• Sr. Staff Embedded Software Engineer

    Abbott (Alameda, CA)
    …the development, verification, ensuring timely delivery and adherence to FDA -compliant design control procedures. They provide technical leadership, mentoring, and ... biowearable products, ensuring on-time delivery within budget. + Implement FDA -compliant design control procedures. + Provide technical leadership and mentoring… more
    Abbott (10/12/25)
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  • QA Supervisor

    Astrix Technology (Anaheim, CA)
    …oversee daily QA operations, ensure regulatory and food safety compliance (eg, FDA , FSMA, GFSI), and support continuous improvement initiatives to uphold the highest ... Conduct internal audits and assist with external audits (eg, FDA , third-party, customer). + Train and mentor QA technicians...in a food manufacturing environment + Strong knowledge of FDA regulations, HACCP, GMP, and GFSI standards (SQF, BRC,… more
    Astrix Technology (10/12/25)
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  • Head of Medical Device & SaMD Quality

    Takeda Pharmaceuticals (Lexington, MA)
    …+ Ensure global compliance with applicable medical device and software regulations (eg, FDA 21 CFR Part 820, ISO 13485, ISO 14971, MDR/IVDR, MDSAP). + Act ... of global regulations and guidances governing medical device, including FDA 21 CFR Part 820, ISO 13485, ISO 14971,...In-depth knowledge of global medical device and SaMD regulations ( FDA , ISO 13485, ISO 14971, MDR/IVDR, MDSAP). + Proven… more
    Takeda Pharmaceuticals (10/10/25)
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  • Senior Design Engineer

    Hologic (Newark, DE)
    …for verification/validation activities. + Maintain accurate records and documentation per FDA and other regulatory requirements. + Interact with internal and ... process and/or product development environment. **Skills:** + Experience with FDA Quality Systems Regulation, especially Design Control requirements, ISO 13485,… more
    Hologic (10/10/25)
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  • Senior Post Market Quality Engineer

    Hologic (Newark, DE)
    …in internal and external audits, including facility, supplier, Notified Body, and FDA inspections. + Own preparation and presentation of materials for monthly ... preferred). **Experience:** + 5+ years of engineering experience in an FDA -regulated industry. + Demonstrated leadership in root cause analysis, complaint… more
    Hologic (10/10/25)
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  • Radiologist - Nuclear Medicine

    Penn State Health (Hershey, PA)
    …X-ray Absorptiometry The Nuclear Medicine Division performs all types of FDA -approved oncologic PET/CT, Amyloid and metabolic brain PET/CT, cardiac Rb-82 PET/CT, ... all types of FDA -approved SPECT/CT exams, and all of the standard planar...of the standard planar exams. Our physicians supervise all FDA -approved adult radiopharmaceutical therapies. Hershey, PA is a town… more
    Penn State Health (10/09/25)
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  • Senior Director, Quality Operations - Solid Dose

    United Therapeutics (Research Triangle Park, NC)
    …pulmonary arterial hypertension ( **PAH** ). Today, we have six FDA -approved therapies that treat PAH, pulmonary hypertension associated with interstitial lung ... advanced working knowledge and experience with cGMPs and US FDA , EU and JP requirements + 5+ years of...HPLC, GC, UV/VIS, FTIR + Knowledge and experience in FDA , USP and EP testing requirements + Detail oriented,… more
    United Therapeutics (10/09/25)
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  • Associate Director, Regulatory

    University of Pennsylvania (Philadelphia, PA)
    …external entities including pharmaceutical companies, contract research organizations (CROs), the FDA , and research networks such as the National Cancer Institute ... representing the department/division related to regulatory audits by the FDA , EMA, other Competent Health Authorities and other University Departments.They… more
    University of Pennsylvania (10/09/25)
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  • Senior Regulatory Compliance Coordinator - Tisch…

    Mount Sinai Health System (New York, NY)
    …Drug (IND) Applications and obtains approval from the Food and Drug Administration ( FDA ) for investigator-initiated clinical trials. Acts as primary contact for all ... FDA communication, including submission of serious adverse events, amendments,...clinical trial status on clinicaltrials.gov website as mandated by FDA and National Institutes of Health (NIH). Analyzes moderate… more
    Mount Sinai Health System (10/08/25)
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  • Clinical Research Coordinator 2 - Surgical…

    Stanford University (Stanford, CA)
    …for multiple studies. Complete annual reports to Institutional Review Board, CSTA, FDA and other regulatory agencies. Submit Investigational New Drug applications to ... the FDA as required. + Audit operations, including laboratory procedures,...and regulatory or governing bodies, which include HIPAA and FDA regulations, Institutional Review Board requirements, and Good Clinical… more
    Stanford University (10/07/25)
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