Bausch Health

  • Sr Manager/Associate Director, Nonclinical

    Location US-NY-Rochester | US-NJ-Bridgewater
    Job ID
    12349
    Category
    R&D
    Pos. Type
    Full Time
  • Overview

    The Sr. Manager/Assoc. Director within Nonclinical Safety will support the research and development of new ophthalmic medical device products as well as maintenance of business activities by ensuring that adequate documentation exists for all new and existing products to meet existing and emerging regulatory requirements, particularly the EU Medical Device Regulations (EU MDR) and ISO 10993 series.

    Responsibilities

    Represent the Nonclinical Safety function within site, managing a team of scientists and serving as core team project member. Additional responsibilities include authoring and providing guidance on risk assessments (products, formulations/ingredients/materials, impurities, leachables and extractables), authoring regulatory documents, and interacting with Health Authorities. 

     

    Specific Job Duties:

    • Manage technical conduct of risk assessments on products, ingredients/materials, impurities and formulations, and authoring of safety assessment documents. Primary contributor as needed
    • Responsible for meeting scope and timelines of Nonclinical Safety deliverables to project teams
    • Review, assess and address any gaps for legacy devices and related documentation to ensure biocompatibility and appropriate Regulatory and Quality compliance.
    • Oversee development and maintenance of nonclinical safety/biocompatibility documents to support EU Medical Device Regulations (MDR) Technical Files
    • Manage relevant standards and regulations.
    • Mentor junior staff

     

    Scope of Position:

    This position is primarily focused on the development of new products as well as supporting maintenance of business for surgical products/equipment. Position will manage small group of scientists within site.

     

    Key Relationships:

    The position interacts directly with B+L functional groups including R&D groups in Rochester, St. Louis, Irvine and Clearwater.  Also Regulatory, Analytical Chemistry, and Quality groups in the various business units.

    Qualifications

    The position requires a Master or PhD degree in toxicology or a related biological science field, or regulatory affairs.

     

    The position requires a minimum of 5 years (Sr. Manager) or 8 years (Assoc. Director) in regulatory toxicology for medical devices; experience with ophthalmic surgical products/equipment highly preferred. 

    • Expert in US and global regulations (e.g., EU, China, Korea and Japan) and requirements for biocompatibility and safety testing, particularly ISO 10993
    • Experience working with global regulations and requirements, especially the EU Medical Device Directives (MDD) and Medical Device Regulations (MDR).
    • Experience in managing nonclinical safety studies at external facilities
    • Experience working in Design Control (e.g. PDP) environment
    • Strong computer and general software skills; familiarity with Documentum preferred
    • Strong oral/written communication skills 

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