Bausch Health

  • Senior Scientist / Research Scientist, Toxicology

    Location US-NY-Rochester
    Job ID
    12736
    Category
    R&D
    Pos. Type
    Full Time
  • Overview

    This position within Nonclinical Safety will support the B+L Surgical and Vision Care Business Units by ensuring that adequate biocompatibility documentation exists for all new and existing medical device products to meet current and emerging regulatory requirements, particularly the EU Medical Device Regulations (EU MDR) and ISO 10993 series.

     

    Supports MDR work project (technical files): documentation specialist, in compliance to current standards; needs some experience in non-clinical studies or education – understand the science and update the documents
    - Must be in Rochester, NY to support MDR

    Responsibilities

    • Assist in the authoring and review of nonclinical safety/biocompatibility documents.
    • Responsible for maintenance and update of nonclinical safety/biocompatibility documents based on new regulatory requirements and/or information, primarily related to EU MDR Technical Files.
    • Conduct restricted substance assessments under the EU MDR.
    • Assist in activities related to the management of global regulations and standards relevant to nonclinical safety. Track changes and conduct gap assessments, and communicate to team.
    • Conduct gap assessments to determine the impact of changes in regulatory requirements to the biocompatibility of existing products by evaluation of available data (e.g. test reports, literature) and/or execution of toxicology studies at external vendors.
    • .
    • Serve as the Nonclinical Safety Group Subject Matter Expert (SME) in biocompatibility related regulations (e.g., EU MDD, EU MDR) and standards (e.g., ISO 10993 series).
    • Assist Regulatory Affairs with periodic updates to EU Technical Files to support EU recertifications and responding to Notified Bodies queries.

    Scope of Position: Individual contributor to product life cycle management activities and to a lesser extent to new product development activities.

     

    Competencies

    • Individual with strong emphasis on the regulatory requirements related to medical devices to ensure continued compliance, particularly biocompatibility requirements in the US and EU. Responsible for managing relevant projects of limited scope or parts of larger and more complex ones
    • Organizes and carries out work on projects under the mentorship of a Director and/or Principal Scientist.
    • Assists with execution of regulatory activities related to the nonclinical function. Develops and implements processes, procedures and documents to assist streamline nonclinical safety activities.
    • Level of empowerment: Execution of tasks and empowered to refine and improve execution.
    • Problem Solving: Conceives solutions and applies to solve problems of medium complexity with independence.

     

    Key Relationships:

    R&D organization (Regulatory Affairs, Quality, Analytical Chemistry, Formulations, Engineering, Project Management) and external vendors (CROs and consultants)

    Qualifications

    Degree in Toxicology, Regulatory Affairs, or related discipline. MS with experience in toxicology or related discipline with a minimum of 2 years relevant industry experience; BA/BS with a minimum of 5 years relevant industry experience.·        

    • Knowledgeable of global medical device regulations (e.g., US FDA, EU, Japan MHLW), especially the EU Medical Device Directives (MDD) and Medical Device Regulations (MDR).
    • Knowledgeable in global standards (e.g., ISO 10993 series) and compendia (e.g. USP, JP,EP) related to medical devices.
    • Basic understanding of good laboratory practice (GLP) regulations.
    • Experience in designing and monitoring nonclinical studies at CROs, and analyzing/presenting data.
    • Experience in conducting gap assessment of global standards.
    • Experience in drafting and reviewing biocompatibility and/or safety assessments, researching literature and toxicology database resources, and summarizing information.

     

    Special Skills:  Computer Literacy with skills in Microsoft Excel, Word, Project and PowerPoint. Strong Communication, Organization, Report Writing, and Presentation skills a must.  Must be able to develop working relationships with various internal core competencies, manage outside suppliers, influence others outside of their immediate control and lead team members

     

    Entry Level - 5 years in Toxicology and/or Regulatory Affairs in pharmaceutical and/or medical device industry

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