• Manager, Regulatory Affairs

    Globus Medical, Inc. (Audubon, PA)
    … Regulatory team in preparing and filing 510(k), IDE, PMA submissions, FDA reports, all international regulatory submissions and registrations, responds to ... sense of urgency to deliver innovations that improve the quality of life of patients with musculoskeletal disorders. Our...conformance to 21 CFR regulations. + Assists with other regulatory matters as requested. + Attends FDA … more
    Globus Medical, Inc. (12/23/25)
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  • Vice President, Regulatory Affairs…

    Sumitomo Pharma (Harrisburg, PA)
    …clinical regulatory strategies including management of IND and NDA submissions, FDA and other global regulatory interactions, as well as international ... the quality and scientific integrity of documents submitted to regulatory authorities + In collaboration with Commercial, Medical and Legal colleagues, conduct… more
    Sumitomo Pharma (12/23/25)
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  • Regulatory Affairs Manager

    Dentsply Sirona (York, PA)
    …device industry. + Experience with leading regulatory submissions and managing regulatory projects. + In-depth knowledge of FDA 510(k) and international ... communication skills. + Prior technical writing experience and proven track record with FDA and EU regulatory submissions. + Excellent interpersonal skills. +… more
    Dentsply Sirona (12/17/25)
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  • Senior Manager, CMC Global Regulatory…

    Otsuka America Pharmaceutical Inc. (Harrisburg, PA)
    …drug products and drug-device combination products. Ensure compliance with global regulations ( FDA , EMA, ICH, WHO) and anticipate regulatory changes impacting ... as CMC regulatory lead on global project teams (Pharmaceutical Development, Quality , Manufacturing, Global Regulatory Strategy). + Assess and provide … more
    Otsuka America Pharmaceutical Inc. (12/02/25)
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  • Regulatory Associate

    Globus Medical, Inc. (Audubon, PA)
    …we move with a sense of urgency to deliver innovations that improve the quality of life of patients with musculoskeletal disorders. Our team is inspired by the ... lives as quickly as possible. **Position Summary** **:** The Regulatory Affairs Associate assists in 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. (10/18/25)
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  • Associate Director, Regulatory

    University of Pennsylvania (Philadelphia, PA)
    …and serve as a key departmental stakeholder representing the department/division related to regulatory audits by the FDA , EMA, other Competent Health Authorities ... programs and resources, and much more. Posted Job Title Associate Director, Regulatory Job Profile Title Associate Director, Clinical Research Regulatory Job… more
    University of Pennsylvania (01/07/26)
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  • Principal Regulatory Affairs Specialist

    Philips (New Kensington, PA)
    …right fit if:** + You've acquired a minimum of 7+ years' experience in Regulatory Affairs/Strategy within FDA regulated Medical Device environments. + You have ... The Principal Regulatory Affairs Specialist will develop and execute the...EUMDR tech files, and Pre-Sub notifications submitted to the FDA . + Your skills include familiarity with FDA… more
    Philips (11/11/25)
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  • Regulatory Affairs Associate Director, IVD

    GRAIL (Harrisburg, PA)
    …Regulatory affairs and IVD device experience required. + Direct experience with FDA regulatory submissions required. + Demonstrated knowledge of US and ... Quality , Lab Operations, and other stakeholders to support regulatory strategy development, product validation, audits, promotional material review, on-market… more
    GRAIL (12/03/25)
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  • Senior Manager, Global Regulatory Affairs

    Otsuka America Pharmaceutical Inc. (Harrisburg, PA)
    **Position Summary** Provides critical support in developing global regulatory strategy, planning and execution of global investigational and marketed prescription ... activities for all assigned projects in alignment with the Global Regulatory Lead. Translates complex pertinent global requirements and provides an assessment… more
    Otsuka America Pharmaceutical Inc. (11/20/25)
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  • Sr. Scientist, R&D

    Teleflex (Wyomissing, PA)
    …control processes, agile systems, and creation of design documentation. * Solid knowledge of regulatory and quality standards ( FDA 21 CFR Part 820, ISO ... Acting as a subject matter expert, this position collaborates across functions, supports quality and regulatory initiatives, and represents R&D in internal and… more
    Teleflex (12/24/25)
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