As an individual contributor, the function of the Associate Regulatory Affairs Specialist is to support the Regulatory Affairs function and systems. collaborates cross functionally on project teams to direct completion of regulatory requirements to assure successful new product registrations, or in support to changes to existing products. The individual will prepare and submit documentation needed for registrations globally. This involves regular high-level analysis and interpretation of government medical device regulation and guidance, strategy development, project management of deliverables and tracking through to completion.