Bausch Health

  • Sr. Manager, Regulatory Affairs

    Job Location US-MO-St Louis
    Job ID
    11244
    Pos. Category
    R&D
  • Overview

    Handle all regulatory aspects for assigned Business Unit. Participates on product development teams, including new product, geographic expansion, and maintenance of business. Interacts with Regulatory Authorities and interfaces frequently with B+L regional regulatory partners.

    Responsibilities

    • Prepare US and non-US submissions (510(k), PMA, IDE, CE Applications and technical files
    • Review and approve labelling and promotional materials
    • Develop and recommend regulatory strategies
    • Assist in the review and policies and procedures.
    • Interact with the FDA and other regulatory agencies
    • Provide coaching to regulatory specialists

    Scope of Position:

    Focus slightly weighted to EU MDR submission work.

     Balance is roughly 60% International and 40% domestic.

     

    Key Relationships: Internal Global and regional Regulatory Affairs partners, as well as internal cross-functional interacts with external regulatory authorities.

    Qualifications

    Required Education:

    Bachelor’s degree in science or health related field required.

     

    Preferred Education: Advance degree preferred (PhD, MD, MS, PharmD, or equivalent)

     

    Required Skills/Qualifications:

    Must possess at least a mastery level of performance in the majority of the following core competencies:  influence key stake holders, business acumen, project management, relationship building, regulatory expertise.

     

    Preferred Skills/Qualifications: Regulatory Affairs Certification

     

    Required Experience:

    7-10 years regulatory experience with medical devices

     

    Preferred Experience: 10+ years regulatory experience with medical devices

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