Regulatory Submission Specialist (EU IVDR / CE-mark))

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How many years of experience do you have in regulatory affairs for IVDs and/or medical devices? *

Have you contributed to a CE-marking submission or technical documentation under EU IVDR? If yes, briefly describe your role. *

Which IVD performance documents or studies have you worked with? Please select all that apply: analytical performance, clinical performance, performance evaluation report, risk management, usability/lay-user study, stability, labelling/IFU, post-market su *

Have you worked on self-test, at-home-use, women’s health, fertility, or consumer diagnostic products? Please briefly describe. *

Are you able to work remotely on a full-time basis and maintain occasional overlap with US working hours? *

What are your monthly salary expectations in USD for a B2B contract? *

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