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    Regulatory Affairs Project Leader #: - Santa Clara, United States - Hiretalent Group

    Hiretalent Group
    Hiretalent Group Santa Clara, United States

    4 weeks ago

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    Description

    Regulatory Affairs Project Leader #:
    weeks ago Be among the first 25 applicantsExempt/Non-Exempt: Non-exemptEducation: Bachelor's degree required, Masters degree preferredExperience: Minimum of 3 years experienceSkills: Knowledge of US and/or Canadian regulation relating to product and/or device clearance (FDA)

    Duties:
    Assists in definition/implementation of regulatory strategy and priorities in conjunction with management, peers, commercial, and affiliate personnel. Communicates issues to management through project management tracking and issue briefings. Position is highly visible to internal and external stakeholders.

    High level of effective verbal and written communication skills must be demonstrated, including ability to negotiate, influence, and manage conflict.

    Prior regulatory experience in the medical device, food, dietary supplement or pharmaceutical industry is strongly preferred, but not required.

    Ability to work constructively, decisively, and collegiality with internal customers (scientists, marketing, quality assurance, product development, affiliates) to solve problems and communicate regulatory needs.

    Ability to manage and track broad and strategic projects. Ability to communicate effectively in writing crisp briefings and issue analysis. Demonstrated ability to work effectively in a team environment.

    Responsible for tracking and timely completion of regulatory strategies and issues, scientific substantiation for product claims, and label/promotional material activities.

    Responsible for effective communication of regulatory requirements to project teams and internal customers.
    Equivalent to Grade 18 at *** .Seniority level Seniority level Mid-Senior levelEmployment type Employment type ContractJob function Job function LegalIndustries IT Services and IT Consulting, Accounting, and Financial ServicesReferrals increase your chances of interviewing at HireTalent
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