Regulatory Affairs Specialist
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About The Position
At Enovis™ we pay attention to the details. We embrace collaboration with our partners and patients, and take pride in the pursuit of scientific excellence — with the goal of transforming medical technology as we know it. Because that’s how we change the lives of patients for the better. And that’s how we create better together. We are seeking a skilled and experienced Regulatory Affairs Specialist to join our team. The Regulatory Affairs Specialist will be supporting a wide range of regulatory activities to ensure compliance with global submission requirements, departmental processes, and quality system standards. This role will develop regulatory strategies, complete impact assessments, and prepare submissions including U.S. FDA 510(k)s, EU MDR Technical Documentation and other OUS registrations. The RA Specialist will support the Foot & Ankle Business Unit (F&A BU), contribute to new product development and sustaining projects, and engage with global regulatory authorities including the FDA and EU Notified Body.
