Regulatory Affairs Specialist

Job description

Description Since 1985, our core business has been enteral device product development, design, manufacturing, and engineering in a state-of-the-art facility near Cleveland, Ohio. AMT’s steady growth consistently creates job opportunities in Northeast Ohio. We are always searching for new talent and would love for you to join our team! We strive to keep the small company feeling while still reaching users all over the globe. Position Summary: This position is responsible for preparing submissions to various regulatory agencies. Additionally, the position will help maintain and improve upon domestic and international compliance. Candidate must possess the ability to work well in a team environment and demonstrate great attention to detail. Duties and Responsibilities: This list is not comprehensive but meant to represent the most common or important duties of the position. Other duties may be assigned. - Prepare and submit regulatory documentation, such as FDA 510(k) premarket notifications, to regulatory agencies, including FDA, Notified Bodies, and Authorized Representatives. - Prepare, maintain, and submit, when necessary, European Medical Device Directive and European Medical Dev...