Jobs

    Specialist II, Regulatory Affairs - Covington, United States - BD

    BD
    BD Covington, United States

    2 weeks ago

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    Description
    Job Description Summary


    As Regulatory Affairs Specialist II, you will be responsible for the implementation of strategies including domestic and international submissions and other product project team supports.

    This is a hybrid position where the candidate is required to be in the office a minimum of 3 days a week.

    Office location is Covington, Georgia.
    Job Description

    We are

    the makers of possible
    BD is one of the largest global medical technology companies in the world. Advancing the world of health is our Purpose, and it's no small feat.

    It takes the imagination and passion of all of us—from design and engineering to the manufacturing and marketing of our billions of MedTech products per year—to look at the impossible and find transformative solutions that turn dreams into possibilities.

    We believe that the human element, across our global teams, is what allows us to continually evolve. Join us and discover an environment in which you'll be supported to learn, grow and become your best self. Become a

    maker of possible

    with us.

    Key responsibilities will include:

    Provide regulatory support through the product life cycle on product project teams (e.g., developing regulatory strategies, timeline development, change control and preparing submission related documents)

    Prepare and audit 510(k)s, IDEs, PMA and/or international submissions as required

    Provide technical collaboration with FDA and international reviewers and respond to questions

    Provide timely review and approval of product labeling and marketing claims for regulatory compliance

    Prepare and update STED technical files for CE marking activities and notified body interaction

    May direct Project Team associates

    About you:

    To be successful in this role, you require:

    Must have knowledge of U.S. and European medical device regulations

    Must have excellent written and verbal communication skills

    Must be self-motivated, work independently and have the ability to take ownership of responsibilities

    Must be able to prioritize and handle several projects concurrently

    Must have technical writing skills and be proficient at compiling successful submissions for the appropriate audience

    Must be able to maintain confidentiality in dealing with regulatory and clinical documentation

    Education and/or Experience

    :

    BS in a Scientific field with 3-5 years of validated experience in the areas of product registration, compliance or quality systems; or a combination of equivalent education and experience

    Regulatory Affairs Certification (RAC) desired

    #J-18808-Ljbffr
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