Strategic Regulatory Affairs Leader – Invasive Medical Devices

A leading medical device company is seeking a Director of Regulatory Affairs to lead regulatory strategy and submissions for invasive electromechanical devices. The ideal candidate will have over 10 years of regulatory experience, especially with 510(k) notifications and EU MDR compliance. This role requires exceptional leadership, analytical problem-solving skills, and the ability to collaborate effectively across departments. The position may involve travel up to 25% domestically and internationally, aligning regulatory strategies with corporate objectives.
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