• Group Engineering Manager, Algorithms & Software

    Globus Medical, Inc. (Methuen, MA)
    …technologies. + Support design transfer from R&D to production under ISO 13485 and FDA guidelines. + ** Regulatory & Quality Compliance** + Ensure adherence ... 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… more
    Globus Medical, Inc. (11/06/25)
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  • Sr. Mgr., Regulatory Affairs (RA)…

    Evident Scientific (Needham, MA)
    …and US Regulatory Compliance, leading end-to-end clinical programs and ensuring regulatory alignment with FDA and global standards. The position serves as ... clinical evidence synthesis. + Ensure alignment between clinical data, labeling, and regulatory claims. **Post-Market Compliance & Quality Interface** + Oversee… more
    Evident Scientific (11/26/25)
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  • Vice President, Regulatory Affairs…

    Sumitomo Pharma (Boston, MA)
    …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 (09/23/25)
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  • Regulatory Affairs Manager

    Dentsply Sirona (Waltham, MA)
    …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 (09/18/25)
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  • Regulatory Coordinator - Breast Oncology

    Dana-Farber Cancer Institute (Boston, MA)
    …documents for SRC and IRB review and approval. + Prepares and submits regulatory documentation that may include; IND/IDE applications, FDA annual reports, ... Office for Human Research Studies (OHRS), Office of Data Quality (ODQ) and the Clinical Trials Offices at the...regulatory agencies including the Food and Drug Administration ( FDA ), Office of Biotechnology Activities (OBA), etc. + Prepares,… more
    Dana-Farber Cancer Institute (11/26/25)
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  • Senior Manager, CMC Global Regulatory…

    Otsuka America Pharmaceutical Inc. (Boston, MA)
    …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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  • Principal Regulatory Affairs Specialist

    Philips (Cambridge, MA)
    …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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  • Senior Director, Global Regulatory Lead…

    Takeda Pharmaceuticals (Boston, MA)
    …for Late-Stage assets. + Solid working knowledge of drug development process and regulatory requirements. Knowledge of FDA , EU, Canada, ROW and post-marketing a ... patients worldwide. Join Takeda as a Senior Director, Global Regulatory Lead - Oncology, where you will be part...a professional and timely manner. + Accountable for US FDA submissions and approvals of project(s) of responsibility. May… more
    Takeda Pharmaceuticals (11/01/25)
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  • Director, Global Regulatory Lead - Oncology

    Takeda Pharmaceuticals (Boston, MA)
    … and/or related experience. + Solid working knowledge of drug development process and regulatory requirements. Knowledge of FDA is a must. Knowledge of EU, ... on patients worldwide. Join Takeda as a Director, Global Regulatory Lead Oncology where you will be part of...lead as a member of a GRT + Primary FDA contact for projects of responsibility. + Accountable for… more
    Takeda Pharmaceuticals (10/30/25)
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  • Global Regulatory Affairs CMC Lead

    Sanofi Group (Framingham, MA)
    …including FDA and EMA. You'll collaborate across R&D, Manufacturing, and Quality teams while preparing high- quality regulatory submissions, managing ... + Act as direct liaison with agencies like US FDA and EMA + Develop positive relationships with regulators...documentation and submissions** + Write, prepare, review, and approve regulatory CMC dossiers + Ensure dossiers meet quality… more
    Sanofi Group (10/15/25)
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