C. R. Bard, Inc.

  • Sr. Regulatory Affairs Specialist

    Posted Date 2 months ago(9/10/2018 3:07 PM)
    Job ID
    Career Level
    BDI Surgery
  • Summary of Position with General Responsibilities

    Manage regulatory projects to ensure timely introduction of new products subject to medical
    device and combination product regulations in U.S. and global regions. Provide technical and
    administrative regulatory support to marketed products and ensure company’s regulatory
    compliance status.

    Essential Job Functions

    1. Prepare and submit applications to the FDA for clinical testing and marketing of new/modified
    medical devices (e.g., 510(k)’s, IDE’s, PMA’s, PMA supplemental applications)
    2. Support in determination of the appropriate regulatory submission requirements and strategies
    for new or modified products. Prepare required documentation as needed (e.g., No 510(k)
    Rationales, international change notifications).
    3. Coordinate review of FDA submissions and test protocols with Corporate Regulatory, Medi cal
    and Legal Departments, and respond to any questions posed by these departments or the FDA.
    4. Prepare application documentation for international marketing approvals (i.e. CE Mark
    Technical files and Dossiers, JSTD, International Dossier).
    5. Assist Product Development and Quality Assurance in planning pre-clinical studies and bench
    testing that will ultimately be used in regulatory submissions.
    6. Assist in the review of proposals for clinical design validations, clinical field trials and
    customer preference tests.
    7. Represent regulatory affairs on product development teams to provide direction with respect to
    regulatory/clinical requirements and strategy.
    8. Assist in development of new product instructions for use/promotional material. Review
    product labeling for compliance with medical device regulations and Division/Corporate
    9. Provide marketed product regulatory support for change management activities, product
    registrations, and business improvement activities.
    10. Support due diligence and business integration activities as assigned.
    11. Support the development and implementation of Davol and Bard regulatory processes,
    procedures, and standards as assigned.

    Basic Qualifications

    B.S. or equivalent with emphasis on Life Sciences. Professional certifications and advanced
    degree preferred.

    - Knowledge and experience (5+ years) with regulatory requirements for medical devices and /
    or combination products (IDE’s, PMA’s ,510(k)’s, CE mark technical files and design
    - Good oral and written communications skills - analytical thinking and technical writing; ability
    to work on cross-functional teams; ability to manage several parallel deliverables.
    - Working knowledge of statistics and electronic documentation and information systems.
    - Ability and desire to travel as needed.

    Additional Desirable Qualifications Skills and Knowledge

    Key Relationships

    Internal Relationships:
    Quality Assurance
    Research and Development
    Manufacturing Operations

    External Relationships:
    Corporate Regulatory, Medical, and Legal
    Bard International Business Centers RA
    Food and Drug Administration
    Notified Bodies
    Competent Authorities

    Training Required
    See Department training matrix – training category program code # 290406
    Scope and Impact of Position:
    This position will play a key role in the new product evaluation and new product submission
    process as well as maintenance of existing product life cycles. Key responsibilities involve
    assurance that clinical evaluations and new product submissions are in compliance with
    applicable global medical device regulations, and regulatory support of change management

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