• Ensure domestic and international regulatory submission and reporting activities are completed in a timely manner • Prepare domestic and international product submission and reports including: U.S. FDA 510(k)s, IDEs, PMAs, annual reports, international product registrations, MDRs, Vigilance Reports and Problem Reports • Prepare Technical Files • Prepare and review product labeling • Prepare correction and removal (recall) reports and coordinate recall related activities • Provide regulatory affairs support to project teams • Develop regulatory strategies for new products • Review design changes and assess regulatory implication relative to the design change • Provide regulatory support for quality system related changes i.e. ECOs, MCOs, NCMRs, SDRs, etc. • Help drive process and compliance improvements activities • Lead health hazard evaluations to determine risk associated with post-market product issues • Provide regulatory affairs support during external inspections (FDA, BSI, etc.) • Provide regulatory affairs guidance to other Orthofix departments, as necessary