Build a career powered by innovations that matter! At Novanta, our innovations power technology products that are transforming healthcare and advanced manufacturing-improving productivity, enhancing people's lives and redefining what's possible. We create for our global customers engineered components and sub-systems that deliver extreme precision and performance for a range of mission-critical applications-from minimally invasive surgery to robotics to 3D metal printing.
Novanta is one global team with over 26 offices located in The Americas, Europe and Asia-Pacific. Looking for a great place to work? You have found it with a culture that embraces teamwork, collaboration and empowerment. Come explore Novanta. Business Unit Overview This position is part of Novanta's Advanced surgery business unit. Specialized in the field of Minimally Invasive Medicine, WOM develops devices and accessories so that doctors can operate with small cuts. We produce Cameras, Insufflators, Medical Pumps, and tubing that makes diagnosis and treatment easier for everyone. Our insufflators and pump systems dilate cavities in the body and turn previously complicated surgeries into minor procedures. Together with customers, doctors, and technical experts, our teams continuously search for new ways to innovate. Summary As a Senior Regulatory Affairs Specialist - FDA , you will be the go-to expert for U.S. regulatory strategy and compliance. In this role, you'll lead FDA submission activities, serve as the primary liaison with regulatory authorities, and partner with cross-functional teams to ensure our products meet the highest standards of safety and effectiveness. This role is responsible for developing and executing FDA submission plans, including 510(k) applications, and serving as the primary liaison with regulatory authorities. The specialist ensures adherence to design control and change management processes, supports audits and customer interactions, and manages safety-related complaints in collaboration with Medical Affairs. Additionally, the position drives initiatives to maintain the Quality Management System and monitors evolving regulatory requirements to keep the organization compliant and competitive. Primary ResponsibilitiesFounded in 1908, Settlement Music School, a non-profit organization, is one of the largest community schools of the arts in the United... ...Arts School.Settlement Music Schools Kardon Center for Arts Therapy is currently seeking part-time contracted creative arts therapists...
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