• R&D Regulatory Manager

    Grifols Shared Services North America, Inc (Worcester, MA)
    …regulatory strategies for projects and issues affecting development of new products or medical devices or new indications for existing products + Provides ... submissions. + May supervise staff + May have responsibility for maintaining a compliant medical device quality system for R&D and informing project teams of… more
    Grifols Shared Services North America, Inc (08/01/25)
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  • Senior Director, Global Regulatory Affairs…

    Takeda Pharmaceuticals (Lexington, MA)
    …Advanced Degree (MS), with Ph.D. preferred. + 15+ years of seasoned biopharmaceutical/ device industry experience or with a regulatory agency, while leading ... role is within in the R&D GRA Chemistry Manufacturing & Controls (CMC) and Devices organization, and will contribute to the team's delivery of critical functions as… more
    Takeda Pharmaceuticals (07/30/25)
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  • Senior Copywriter

    Cramer (Norwood, MA)
    …you need a strict eye for detail to ensure our work adheres to regulatory , legal, and medical guidelines. Your day-to-day will include researching, creating, ... who can take direction and work independently-a creative thinker who never forgets regulatory rules-and excited to work closely with internal and external teams to… more
    Cramer (06/27/25)
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  • Director, Regulatory Site CMC

    Takeda Pharmaceuticals (Boston, MA)
    …years of overall biopharmaceutical/ device industry experience with 8+ years of direct Regulatory CMC or Regulatory Device experience required. This can ... in order to bring life-changing therapies to patients worldwide. The Director Regulatory Site CMC ensures efficient and compliant management of regulatory … more
    Takeda Pharmaceuticals (06/04/25)
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  • Associate Director, Regulatory Affairs

    United Therapeutics (Boston, MA)
    …), livers ( **miroliver(R)** ), and a bioengineered external liver assist device for acute liver failure ( **miroliver** **_ELAP_** **(R)** ), with plans ... hearts. **Who you are** We are looking for a regulatory strategist who will advise on regulatory ...in the Company's comprehensive benefits suite of programs, including medical / dental / vision / prescription coverage, employee… more
    United Therapeutics (06/14/25)
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  • Director, Global Regulatory Labeling…

    Takeda Pharmaceuticals (Boston, MA)
    …bring life-changing therapies to patients worldwide. Join Takeda as Director, Global Regulatory Labeling Strategy where you will be responsible for the development ... and assures that Takeda labeling content and processes conform to regulatory requirements. **Management of Local Exceptions and LOC Interactions** + Manages… more
    Takeda Pharmaceuticals (07/30/25)
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  • Casino Regulatory Manager

    State of Massachusetts (Plainville, MA)
    …investigations. * Understanding of the operations of gaming establishments, casino games, and devices . * Experience with a casino regulatory agency, and casino ... The Massachusetts Gaming Commission (MGC) seeks to hire a Casino Regulatory Manager assigned to the Plainridge Park Casino in Plainville, MA. Under the direction of… more
    State of Massachusetts (07/04/25)
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  • Quality Engineer II - Design & Reliability…

    Integra LifeSciences (Braintree, MA)
    …related discipline, with 3+ years of experience in Quality Assurance role for medical device or pharmaceutical manufacturing, or equivalent education and years ... testing activities. The role works with Product Development, Project Management, Regulatory , Marketing and Medical Affairs. **ESSENTIAL DUTIES AND… more
    Integra LifeSciences (06/07/25)
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  • Senior Quality Engineer I - Design & Reliability…

    Integra LifeSciences (Braintree, MA)
    …related discipline with 5+ years of experience in Quality Assurance role for medical device or pharmaceutical manufacturing, or equivalent education and years of ... activities. The role works closely with Product Development, Project Management, Regulatory , Marketing and Medical Affairs. **ESSENTIAL DUTIES AND… more
    Integra LifeSciences (05/09/25)
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  • Quality Control Manager

    Kelly Services (Norwood, MA)
    …+ **Hands-on experience with:** + **Root cause analysis and CAPA processes** + ** Regulatory compliance (eg, medical device reporting, product risk ... with **ISO 9001 and ISO 13485** standards and all applicable legal/ regulatory requirements. + Coordinate **internal and external audits** , ensuring timely… more
    Kelly Services (08/01/25)
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