• Regulatory Affairs Specialist

    Astrix Technology (Fort Worth, TX)


    Regulatory Affairs Specialist

     

    Clinical

     

    Fort Worth, TX, US

    Pay Rate Low: 55 | Pay Rate High: 70

    + Added - 30/05/2025

     

    Apply for Job

     

    Exciting development opportunity to work for a global leader dedicated to helping people see brilliantly. The largest device company in the world – with complementary businesses in Surgical and Vision Care.

    Regulatory Affairs Specialist III

    Pay rate: 55.00-70.00 DOE

     

    1 Year contract position

    + Supporting EU MDR compliance and lifecycle change management for medical devices.

    + Works closely with site regulatory teams to manage and submit Notified Body (NB) change notifications, maintain regulatory documentation, and support audits and project timelines.

    + Collaborates cross-functionally to ensure timely, high-quality regulatory submissions and supports continuous improvement initiatives.

    + Support the maintenance of Product and QS EC Certificates (MDD /MDR) and associated documentation.

    Key Requirements:

    + 4+ years in medical device regulatory affairs

    + Experience with European MDR and manufacturing environments

    + Strong background in NB submissions and change management

     

    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

    \#LI-DNP:

    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.