Position Summary: The Principal Regulatory Affairs Specialist is responsible for the development and implementation of the regulatory strategy (as applied to project, process, and/or product) and partners with internal stakeholders (e.g., regions) to align on an optimized regulatory strategy in order to achieve business objectives. This individual will provide hands-on regulatory affairs support for new product marketing approvals and renewals for existing products, including development of regulatory requirements/strategies and preparation of submissions, perform regulatory submission/approval activities for specific complex ACIST Medical Systems products, represent ACIST Regulatory with US and international regulators on submission reviews/approvals and ensure