• Responsible for managing tasks/processes and providing expert guidance on activities related to the design, development, and clearance of new products and product modifications. • Will ensure that new products and documentation related to new product design, development, transfer, validation/verification, labeling, and regulatory submissions are compliant with applicable quality and regulatory requirements. • Serves as the department expert and advisor on specialized activities such as Pre-Submissions, 510(k) submissions, PMAs, combination device applications and post-clearance activities and projects. • Provide guidance and participate in drafting of regulatory submissions for domestic, world-wide commercialization and other business objectives. • Authors and reviews technical protocols and data in support of clinical trials, validation, verification and regulatory submissions. • Provides guidance and participates in evaluation of the regulatory impact of changes associated with product design changes and routine modifications to cleared products. • Reviews, and helps provide guidance for product labeling, including Instructions for Use (IFU/PI), to ensure adherence to applicable regulations and standards. • Provides guidance and participates in implementation of new regulations and standards. • Conducts training of new employees, reviews training documentation for co-workers to ensure compliance to regulations. • Other duties as assigned.