• Represents the Regulatory Affairs function in project teams and leads regulatory projects in accordance with established timelines to meet corporate objectives. • Develops and executes sound regulatory strategies to support business goals. • Oversees and ensures compliance with state, federal, and international medical device regulations and overall regulatory departmental objectives for new and existing products. • Assists with the training and mentoring of other Regulatory Affairs team members. • Represents RA department in assigned project meetings and provides regulatory guidance to ensure adherence with global regulatory requirements as appropriate. • Evaluates possible pathways to marketing authorization and recommends pathway that appropriately weighs the probability of success with potential risks to the business. • Develops and executes sound regulatory strategies to support business goals with minimal oversight. • Assesses product and manufacturing changes and develops well-justified regulatory assessments for each global market. • Reviews and approves document change orders, advertising and promotional material, manufacturing nonconformances, technical documents, test protocols and reports, risk management documents, and labeling documents. • Directly interacts with regulatory bodies in the US and/or international regions to ensure projects remain on track and issues are resolved. • Develops, prepares, and submits high quality technical documentation/submissions for regulatory approval in the US and other international regions. • Establishes timelines, manages sub-team meetings relevant to regulatory processes, and ensures timely execution. • Prepares reports for management and develops metrics and proposals for regulatory process improvements.