Hiring: Regulatory Associate Company: Globus Medical Location: King of Prussia, PA Job Posted Time: 2026-09-10 12:29:19 Target Skills & Keywords : Regulatory Compliance About the job Required Skills: •Partnering with Product Development and management to prepare and review 510(k) submissions •Preparing final 510(k) submissions and obtaining required management approvals •Submitting 510(k) documents and responding to the FDA in a timely manner •Assisting in the completion of IDE submissions for IDE clinical trials •Helping to prepare PMA packages, including non-clinical, manufacturing, and clinical sections •Working with personnel in various functional areas to obtain timely submissions to FDA •Obtaining and reviewing clinical study data with Clinical Data Manager and other Clinical Affairs personnel, as needed for IDE and PMA reporting •Reviewing Document Change Orders for Regulatory compliance, including drawings and labeling changes Interested candidates, please apply directly through the job posting on company's career page or try via AI auto apply on this platform. Don't miss this opportunity to join a forward-thinking team!