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Regulatory Affairs Manager
Asensus has a unique opportunity for a Regulatory Affairs Manager to join our team and help bring an innovative digital surgery product to market. The Regulatory Affairs Manager is responsible for developing global regulatory strategies for surgical robotic medical devices. The individual will plan, prepare, and submit FDA premarket 510(k) submissions and international product registrations. This role will oversee and be consulted on post-market surveillance requirements for global regulatory bodies and is expected to have deep product and regulatory knowledge in order to make decisions independently. This role provides regulatory leadership on project teams as well as mentoring the work of other specialists and associates on the Regulatory team. At Asensus, we are digitizing the
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