• Global Regulatory Affairs Manager

    Astrix Technology (Lake Forest, CA)


    Global Regulatory Affairs Manager

     

    Regulatory Affairs

     

    Lake Forest, CA, US

    Pay Rate Low: 185,000 | Pay Rate High: 240,000

    + Added - 16/07/2025

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    A global medical device organization is seeking a **Global Regulatory Affairs Manager** to lead the development, planning, and implementation of regulatory strategies across complex, high-impact programs. This role involves direct responsibility for regulatory submissions in the **U.S., EU, and Canada** , while supporting global markets as needed. The ideal candidate will bring deep regulatory expertise, strong cross-functional leadership, and the ability to navigate high-risk, high-visibility projects with confidence.

     

    Located in Lake Forest, CA

    Contract position

    Pay:** **$180k - $240k

    Key Responsibilities:

    + Lead the creation and execution of global regulatory strategies for multiple complex programs and platforms.

    + Assess regulatory risk and develop contingency plans, including scenario planning to anticipate regulatory authority responses.

    + Directly manage regulatory submissions in the U.S., EU, and Canada; provide support for additional global markets.

    + Guide and influence technical teams on product lifecycle management, change assessments, and enhancement opportunities.

    + Prepare and submit regulatory dossiers including STeDs, 510(k)s, PMAs, and other key submissions.

    + Monitor and interpret changes in global regulatory requirements; drive implementation of process updates to maintain compliance.

    + Serve as the regulatory lead on cross-functional teams to ensure timely and successful product approvals and maintenance.

    + Support communication strategies and negotiations with regulatory bodies and internal stakeholders for high-risk or complex projects.

    + Ensure timely and accurate responses to regulatory agency inquiries.

    Requirements:

    + Bachelor’s degree in a scientific discipline required;

    + Master’s degree with 4+ years, or PhD with 2+ years of regulatory affairs experience preferred

    + Minimum 5 years of regulatory experience in the medical device industry

    + Demonstrated leadership in global regulatory submissions and strategy

    + Strong experience in submission and change assessment for the U.S. and EU markets

    + Working knowledge of Canadian regulatory requirements is a plus

    + Hands-on experience preparing and managing submissions such as STeDs, 510(k)s, and PMAs

    + Experience conducting change impact assessments for regulatory compliance

    + Proven ability to manage complex regulatory projects and communicate effectively across functional teams

    + Ability to interpret and apply global regulatory guidelines and standards

    Preferred Qualifications:

    + Change assessment and submission experience for Canada

    + Experience supporting global registrations across diverse international markets

     

    "This job description is a complete list of all desired skills, but not all are required. We strongly encourage candidates who have some of the skills to apply. We look forward to a conversation to learn more about you!”

    \#INDBH

    We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.