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San Juan Capistrano

    Director, Regulatory Affairs - San Juan Capistrano, United States - Quest Diagnostics Incorporated

    Quest Diagnostics Incorporated
    Quest Diagnostics Incorporated San Juan Capistrano, United States

    4 weeks ago

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    Description


    The Director, Regulatory Affairs for EMEA is responsible for successful completion of complex regulatory projects, including pre-submissions and IDE submissions to FDA, IRB submissions, Ethics Committee submissions, EU Annex XIV submissions and as well as premarket authorization applications, including PMAs and EU Technical Documentation submissions to the notified body and other ROW regulatory applications.

    Manages team of regulatory and clinical professionals at the Specialist or Manager levels
    Establishes and executes regulatory and clinical strategies, in cooperation with cross-functional project teams.
    Provides guidance to staff on identification of regulatory and clinical requirements and supports staff with the effective implementation
    In cooperation with Head, Quality Assurance & Regulatory Affairs, establishes and maintains appropriate procedures for areas of responsibility
    Supports clinical monitoring activities for clinical studies including companion diagnostics
    Prepares and submits clinical device protocols, IRB applications for initial study start, continuing review and study closure
    Submits Technical Files, pre-subs, IDEs, FDA and EU related activities (i.e., IDE supplements, amendments etc.)
    Leads the IVDR activities for Provisional Transitions for procedures and IVDR requirements
    Collaborates with peers from other functional areas and Project Manager
    Serves as contact point for escalation of regulatory or clinical project challenges
    Interacts with FDA, notified body personnel, EU, legal representative and authorized representative, as needed.
    Provides coaching and professional development to team members
    Incumbent may supervise approximately 5 to 10 team members at the Associate, Specialist or Manager levels

    Minimum of 8 years of related experience in the in vitro diagnostic or medical device industry working on regulatory submissions
    At least 3 years' experience leading teams
    Bachelor's degree is required
    Regulatory Affairs Certification (RAC) required
    At least three years of experience working in regulatory affairs roles on CDx projects within the in vitro diagnostic industry
    Strong verbal and written communication skills.
    Demonstrated success in motivating team members to reach objectives.
    Strong influences skills and excellent interpersonal skills.
    Demonstrated PC experience with SPCXL, MS Word, Excel and PowerPoint
    Knowledge of US and EU regulatory submission requirements

    Skills:
    Able to effect Quality Improvement through problem solving skills and knowledge of quality tools - required
    Able to lead and drive change - required
    Organization skillsrequired
    Project and team management skills - required (Quest Management System skills - preferred)
    Analytical and problem-solving skills - required
    Computer skills, including standard business software tools and typing - required
    Able to function in a matrix organization-desired
    Multi-tasking skills-desired
    Flexibility to meet continuously changing priorities and challenges

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