• Manager, Global Regulatory Affairs

    Hologic (Marlborough, MA)
    …preferred. + A minimum of 8 years of experience in Regulatory Affairs within the Medical Device industry. + Experience authoring/supporting/maintaining ... Manager, Global Regulatory Affairs Marlborough, MA, United States...proficiency working within a QMS. + Firm understanding of regulatory challenges in the medical device… more
    Hologic (07/30/25)
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  • Regulatory Affairs Specialist - Post…

    Canon USA & Affiliates (Boston, MA)
    …including MS Word, Excel, Oracle, Sales Force, etc. + 2 Years Regulatory Affairs experience in medical device industry required + Minimum Education ... ** Regulatory Affairs Specialist - Post Market...$72,000 to max $116,100 (annual equivalency) **_About us!_** _Canon Medical Systems USA, Inc., a world leader in diagnostic… more
    Canon USA & Affiliates (06/07/25)
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  • Program Manager, Regulatory Affairs…

    Olympus Corporation of the Americas (Westborough, MA)
    …and future approvals to management. **Job Qualifications** **Required:** + Regulatory affairs experience in the Medical Device industry is mandatory. ... (https://www.olympusamerica.com/careers) . **Job Description** Assist the Manager, Regulatory Affairs in obtaining approval to market Olympus medical devices… more
    Olympus Corporation of the Americas (06/18/25)
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  • Senior Regulatory Affairs Specialist

    Hologic (Marlborough, MA)
    …scientific discipline (Master's or RAC certification preferred) + 5-8 years' regulatory affairs experience in the medical device industry, ideally with ... Senior Regulatory Affairs Specialist Newark, DE, United...of regulatory compliance for our capital equipment medical device portfolio. Working cross-functionally with R&D,… more
    Hologic (07/19/25)
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  • Director or Regulatory , Software…

    Philips (Cambridge, MA)
    …fit if:** + You've acquired 10+ years of experience working in Regulatory Affairs within the medical device industry; Experience with software-enabled ... **Director, Regulatory Affairs - Software and Artificial Intelligence...and all key stakeholders including R&D, Product Management, Quality, Medical & Clinical Affairs , and other functions… more
    Philips (08/01/25)
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  • Principal Regulatory Affairs…

    Philips (Cambridge, MA)
    …of 8+ years' Regulatory Affairs experience within FDA regulated Medical Device /HealthTech product environments. Experience with Software as Medical ... As a critical member of the Philips Ultrasound- Regulatory Affairs Organization, the Principal ...Technical Documentation, 510(k), De Novo, PMA, and registrations of medical devices globally. + You're able to work in… more
    Philips (06/28/25)
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  • Senior Principal, Regulatory Affairs…

    Danaher Corporation (Boston, MA)
    …(https://www.danaher.com/how-we-work/danaher-business-system) which makes everything possible. The Senior Principal, Regulatory Affairs is responsible for ... pathology in the clinical oncology environment. The Senior Principal, Regulatory Affairs will provide oversight and lead...on the development and registration activities for the respective medical products + Develop and manage regulatory … more
    Danaher Corporation (07/09/25)
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  • Sr. Regulatory Affairs Specialist

    ConvaTec (Lexington, MA)
    …improvements for regulatory affairs systems. + Experience of regulatory requirements for medical devices containing animal derived materials preferred. + ... responsibilities of the position are to drive improvements in regulatory affairs processes, systems and infrastructure whilst...Experience of regulatory requirements for medical Devices with an… more
    ConvaTec (08/02/25)
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  • Director Global Regulatory Affairs…

    Takeda Pharmaceuticals (Boston, MA)
    …of technical success for the solutions. + Effectively represent the Global Regulatory Affairs (GRA) function in senior level interactions at internally ... submissions and their amendments/supplements). + Understanding of scientific principles and regulatory Device requirements relevant to global drug development… more
    Takeda Pharmaceuticals (08/01/25)
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  • Associate Director, Regulatory…

    United Therapeutics (Boston, MA)
    …or pharma regulatory experience with a Bachelor's Degree in life sciences, quality, regulatory affairs or a related area of study or 10+ years of biologic ... ( **miroliver(R)** ), and a bioengineered external liver assist device for acute liver failure ( **miroliver** **_ELAP_** **(R)**...experience with a Master's Degree in life sciences, quality, regulatory affairs or a related area of… more
    United Therapeutics (06/14/25)
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