• Lead new and modified product development projects to establish and integrate regulatory strategy into project activities. • Lead the preparation, submission, and maintenance of global product registrations with a focus on 510(k), EU Technical Documents, and International STEDs. • Collaborate with internal Cardinal Health international regulatory departments to assess international registration requirements, develop international regulatory strategy, and ensure timely execution. • Review design control documents including documents associated with design inputs and design outputs. • Review product labeling for compliance with global labeling regulations. • Interpret and evaluate proposed regulations for medical devices and advise on impact of such regulations to the business. • Maintain regulatory intelligence through continuous monitoring of regulatory landscape; identify risks, mitigation, and resolution strategies. • Maintain and provide regulatory information in support of customer queries, bid and tender submissions, customs queries, etc. • Development and implementation of regulatory procedures and SOPs.