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    Senior Manager of Regulatory Affairs - Lincolnshire, United States - Elite Talent Partners

    Elite Talent Partners
    Elite Talent Partners Lincolnshire, United States

    2 weeks ago

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    Description

    Job Description

    Our client is a globally recognized company that specializes in cutting-edge medical diagnostic equipment, based in Asia. The team is dynamic and dedicated to achieving major advancements in laboratory diagnostics, IT, workflow analysis, and life sciences for clinical laboratories.

    Position: Regulatory Affairs Senior Manager

    • Work arrangement: 50% remote, 50% office
    • Salary: $150k-170k, with a 15% annual bonus
    • Reports to: Director of Regulatory Affairs

    Description:

    We are currently seeking a skilled Regulatory Affairs Senior Manager to lead the regulatory strategy for new and updated medical device products. This individual will spearhead regulatory development, submission strategies, and liaison with regulatory authorities in the US and Canada.


    Key Responsibilities:

    • Lead preparation, documentation, and submission of FDA and Health Canada applications
    • Manage device registrations, listings, and licensing renewals for compliance with regulations
    • Review regulatory materials for accuracy and compliance
    • Provide regulatory guidance to cross-functional teams
    • Ensure sustained regulatory compliance and adherence to internal procedures
    • Maintain knowledge of relevant regulations and guidelines
    • Develop regulatory strategies and provide guidance for planned changes
    • Support post-approval product activities
    • Set team objectives aligned with business and regulatory strategies
    • Other duties as assigned
    • Travel required (5-10%)

    Qualifications:

    • Bachelor's degree in a science-related field
    • Minimum 7+ years experience in Regulatory Affairs in the medical industry
    • Experience working with regulatory agencies
    • Thorough understanding of FDA and Health Canada regulations
    • Knowledge of in vitro diagnostic devices regulations
    • Experience with various medical technologies
    • Excellent IT skills
    • Strong communication and organizational skills
    • Ability to work well under pressure and as part of a team

    Join our team and be part of revolutionizing the medical diagnostic industry!

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