Program Manager, Regulatory Affairs - Canton - Organogenesis

    Organogenesis
    Organogenesis Canton

    1 week ago

    Description

    We are seeking an exceptional Program Manager for Regulatory Affairs who will grow professionally and personally while Empowering Healing.

    As a key member of our team, you will handle regulatory affairs requirements for medical devices and biologic products, including HCT/Ps.

    • You will develop regulatory strategies and submissions for new and modified products to FDA and International bodies
    • Provide regulatory support and guidance for product changes to US marketed products

  • Only for registered members Canton $119,000 - $140,000 (USD)

    Job summary: Join a company where you will have an opportunity to grow professionally and personally and give strength to others by Empowering Healing. We offer a strong benefits package opportunities for growth and the chance to contribute to our mission: · to provide an integr ...

  • Only for registered members Canton, MA

    We have unique opportunities and are always looking for exceptional talent. Join a company where you will have an opportunity to grow professionally and personally and give strength to others by Empowering Healing. · ...

  • Only for registered members Beverly

    This is a Regulatory Affairs & Compliance Lead role at Sensitech, where you will be the regulatory subject-matter expert for their comprehensive product portfolio. · Develop and implement regulatory strategies for new and modified products to enable entry into target markets. · ...

  • Only for registered members Beverly Full time $120,000 - $168,000 (USD)

    Sensitech Inc., a Carrier company under the Climate Solutions Transportation (CST) segment, is a global leader in supply chain visibility solutions. Sensitech helps ensure the quality and integrity of temperature-sensitive products across the pharmaceutical, food, and industrial ...

  • Only for registered members Beverly $120,000 - $168,000 (USD)

    As the Regulatory Affairs & Compliance Lead at Sensitech, you will be the regulatory subject-matter expert for our comprehensive product portfolio. · The Regulatory Affairs & Compliance Lead collaborates cross-functionally with Product Development, Quality, Manufacturing, Marketi ...

  • Only for registered members Beverly, MA

    We are seeking a Regulatory Affairs & Compliance Lead to join our team at Sensitech Inc., a global leader in supply chain visibility solutions. As the regulatory subject-matter expert for our comprehensive product portfolio, you will collaborate cross-functionally with Product De ...

  • Only for registered members Boston

    As a Regulatory Affairs Specialist at Mass General Brigham, you will be responsible for ensuring compliance with regulatory requirements and maintaining an updated library of FDA regulations and guidance documents. · AUTHORS AND REVIEWS OF STANDARD OPERATING PROCEDURES,T techNICA ...

  • Only for registered members Mansfield, MA

    Ensure compliance to FDA and other applicable regulations as Regulatory Affairs Manager. · ...

  • Only for registered members Needham $66,330 - $81,070 (USD)

    The Regulatory Affairs Specialist is responsible for coordinating customer complaints within the organization's Quality Management System (QMS). This role ensures accurate recording and processing of complaints in compliance with internal procedures, ISO 13485, and applicable reg ...

  • Only for registered members Needham $66,330 - $81,070 (USD)

    The Regulatory Affairs Associate role at SharkNinja involves managing customer complaints within the organization's Quality Management System (QMS). This includes reviewing submissions for completeness, logging complaints accurately in the QMS, and ensuring timely progression thr ...

  • Only for registered members Needham, MA

    The Regulatory Affairs Specialist is responsible for coordinating customer complaints and ensuring compliance with internal procedures and regulatory requirements. · Monitor designated sources for new complaints. · Accurately log complaints in the QMS. · ...

  • Only for registered members Mansfield, MA

    This position involves regulatory affairs with Technical Files or equivalent in an R&D or quality position with hands-on experience in the preparation review and/or auditing of medical device DHFs Risk Management files and/or DMRs. · Must have knowledge of European/International ...

  • Only for registered members Cambridge $307,913 - $380,363 (USD)

    +Job Summary · The VP of Regulatory Affairs will lead create and drive the regulatory strategy for life cycle management activities for Vafseo Auryxia and early development programs. · ...

  • Only for registered members Mapleville

    We are looking for a talented and detail-oriented Regulatory Affairs Specialist with 2-3 years of experience in regulatory affairs, · specifically with expertise in regulatory codes, particularly USDA codes.Ensure compliance with regulatory standards and codes governing the food ...

  • Only for registered members Mapleville, RI

    We are looking for a talented and detail-oriented Regulatory Affairs Specialist with 2-3 years of experience in regulatory affairs, specifically with expertise in regulatory codes, · The company offers flexibility for hybrid or remote work arrangements depending on business needs ...

  • Only for registered members Somerville Full time

    Reporting to the Head of Quality, Regulatory, and Compliance, · the Director of Regulatory Affairs is responsible for executing regulatory strategies, · ensuring compliance with global regulations and leading the process to obtain · and maintain market approval for DeepHealth's p ...

  • Only for registered members Cambridge, MA

    Be part of a Regulatory Affairs Team to develop and deploy innovative and compliant regulatory strategies across business and markets to achieve the highest standards for patient safety and product efficacy. · Bachelor's degree or equivalent qualification preferably in Regulatory ...

  • Only for registered members Cambridge Full time $125,000 - $155,000 (USD)

    Beam is seeking a Manager Regulatory Affairs to progress a broad portfolio of advanced genetic medicines in a fast paced and dynamic biotech environment. · ...

  • Only for registered members Boston

    Monte Rosa Therapeutics seeks an experienced Director of Regulatory Affairs to lead global regulatory efforts across development programs in immunology. · ...

  • Only for registered members Burlington Full time $185,000 - $240,000 (USD)

    The Director, · Regulatory Affairs will lead global · regulatory strategy for development-stage · neuroscience programs. · <li_annual bonus opportunity medical dental vision life and AD&D short term long term disability 401(K) plan with match stock options flexible non-accrual pa ...

  • Only for registered members Cambridge

    We are looking for a Regulatory Affairs Specialist to develop and deploy innovative and compliant regulatory strategies across business and markets. · Assist in implementing comprehensive regulatory strategies by collaborating with regulatory subject matter experts (SMEs). · Coor ...

Jobs
>
Canton