• Principal Quality Assurance Engineer

    Hologic (Marlborough, MA)
    …+ Proven track record in quality system strategy, risk management, and regulatory compliance . + Hands-on experience with mergers and acquisitions integration ... to hear from you! **Knowledge:** + In-depth understanding of FDA Quality System Regulations, ISO 13485, and Medical Device...ISO 13485, and Medical Device Directive. + Expertise in compliance issues and regulatory expectations. + Advanced… more
    Hologic (08/26/25)
    - Related Jobs

  • Senior Quality Engineer I - Design & Reliability…

    Integra LifeSciences (Braintree, MA)
    …and manage time to meet organizational goals and objectives. + Experience with External Regulatory Agency audits (ie, Notified Bodies and FDA ). + Knowledge of ... The role works closely with Product Development, Project Management, Regulatory , Marketing and Medical Affairs. **ESSENTIAL DUTIES AND RESPONSIBILITIES** +… more
    Integra LifeSciences (08/08/25)
    - Related Jobs

  • Production Technician

    System One (Devens, MA)
    …technical field (entry-level to 2+ years' experience) + Strong understanding of GMP and FDA regulatory requirements + High level of safety awareness in an ... PPE, including an air helmet. + Accurately complete batch records and documentation in compliance with FDA and cGMP guidelines. + Ensure all production and… more
    System One (08/03/25)
    - Related Jobs

  • Quality Control Technician II, Analytical

    Integra LifeSciences (Boston, MA)
    …A minimum of 2-4 years' experience in a medical device, pharmaceuticals, Quality/ Regulatory Compliance , or other cGMP regulated product preferred environment. + ... and Drug Administration regulations, ISO 13485, and other applicable regulatory agencies as they pertain to laboratory testing. +...(CAPAs). + Assist in preparing for and participating in FDA audits, customer audits, etc. + All other duties… more
    Integra LifeSciences (07/31/25)
    - Related Jobs

  • US Medical Lead, Solid Tumors

    Sanofi Group (Cambridge, MA)
    …including medical science, clinical trials, marketing strategies, and key publications. + ** Regulatory and Compliance Oversight** : Oversee the medical review ... and approval of regulatory documents, ensuring adherence to company standards and government/industry...skills. + Strong understanding of clinical trials processes and FDA approval processes, including accelerated approval, and FDA… more
    Sanofi Group (07/29/25)
    - Related Jobs

  • Quality Engineer II - Design & Reliability…

    Integra LifeSciences (Braintree, MA)
    …and manage time to meet organizational goals and objectives. + Experience with External Regulatory Agency audits (ie, Notified Bodies and FDA ). + Knowledge of ... activities. The role works with Product Development, Project Management, Regulatory , Marketing and Medical Affairs. **ESSENTIAL DUTIES AND RESPONSIBILITIES** +… more
    Integra LifeSciences (06/07/25)
    - Related Jobs

  • Associate Director, Device Clinical Development

    Takeda Pharmaceuticals (Lexington, MA)
    …deliver device clinical outcomes that exceed quality benchmarks and regulatory standards. **Core Responsibilities:** **Device Clinical Strategy & Risk Management:** ... into technical requirements + Coordinate risk mitigation activities across clinical, regulatory , quality, and engineering functions + Perform safety reviews on… more
    Takeda Pharmaceuticals (06/06/25)
    - Related Jobs

  • Manager, Quality Assurance

    Curia (Hopkinton, MA)
    …of the conditions and activities in the manufacturing facility to ensure continual compliance with cGMP. This position requires expertise in all aspects of Biologics ... Through a quality system approach, ensure all GMP operations are in compliance , while maintaining an efficient workflow to facilitate operational excellence +… more
    Curia (08/14/25)
    - Related Jobs

  • Document Control Specialist

    Integra LifeSciences (Braintree, MA)
    …document storage. + Minimum of 1-2 years' experience in a Quality Systems I Regulatory Compliance environment with a working knowledge preferably in the medical ... resources, planning to meet goals and deadlines + This role ensures compliance within the document management system, document storage, retention, and document… more
    Integra LifeSciences (07/16/25)
    - Related Jobs

  • General Counsel: General Counsel & Internal Legal…

    Nanobiosym, Inc. (Cambridge, MA)
    …years of legal experience (in-house and law firm), with expertise in healthcare, regulatory compliance , corporate governance, and IPO preparation. + Strong track ... multi-disciplinary environment and is ready to tackle a wide range of legal, regulatory , and compliance challenges. The ideal candidate is a skilled negotiator,… more
    Nanobiosym, Inc. (07/01/25)
    - Related Jobs