POSITION SUMMARY:We are seeking an experienced Regulatory Affairs Associate to support our Human Health Division, specifically focused on medical device regulatory submissions and compliance. This role is ideal for a detail-oriented professional with a strong understanding and experience of global regulatory requirements and a passion for ensuring patient safety.JOB DUTIES include but are not limited to:Prepare, review and submit regulatory documentation for medical devices (e.g. 510(k), CLIA Waivers and Technical Files)Ensure compliance with FDA, EU IVDR, and other international regulatory requirementsUtilize checklist, symbol standards, and regulatory guidances to ensure label compliance with FDA and global regulatory expectationsCollaborate with business partners to assure timely review, approval and processing of regulatory documentsUtilize systems for entry and tracking of regulatory activitiesManage and communicate accurate timelines for deliverablesRegulatory Assess product changes for global regulatory impact
