Overview At Spacelabs Healthcare, we are on a mission to provide continuous innovation in healthcare technology for better clinical and economic outcomes. Our scalable solutions deliver critical patient data across local and remote systems, enable better-informed decisions, increase efficiencies, and create a safer environment for patients. Why work at Spacelabs? Because lives depend on you! The Regulatory Affairs Specialist II supports the regulatory and product registration activities of the company. This role involves working closely with high-priority regulatory activities, such as MDSAP regions and other primary market registrations. The specialist will collaborate with design control teams to assess the impact of product changes on regulatory obligations and assist in reviewing reported issues for potential adverse events. Additionally, the role includes preparing regulatory documentation for global submission. This RA Specialist will provide technical guidance to team during the course of submission preparation and interaction with regulatory agencies. This position is hybrid/ remote, with the expectation of working onsite 1-2 days per quarter. Responsibilities Coordinate, prepare, and obtain necessary product clearances for moderately complex regulatory submissions, both domestically and internationally. Maintain a system to ensure all international product registrations are current, ensuring products are legally available worldwide. Review reported issues for potential adverse events, prepare reports, and submit them to appropriate government bodies. Prepare required Field Action Plans, Customer Letters, and government notifications as directed. Stay current on changes to worldwide medical device regulations, product registration requirements, and standards, and inform the RA team. Gather and present regulatory performance metrics regularly. Manage communications with external agencies and parties on regulatory matters. Actively participate as the regulatory representative in engineering project, product, and process meetings. Provide input on, review, and approve product and labeling changes for compliance with standards, guidelines, regulations, and regulatory approvals/clearances. Implement global regulatory action plans based on product and labeling changes. Provide general guidance and support to the RA department in all regulatory-related matters. Assist and provide expertise during regulatory inspections. Ensure the effectiveness and currency of the Quality Management System, including adherence to the Quality Manual and supporting Standard Operating Procedures. Enhance regulatory processes and procedures; create and revise work instructions and training as needed. Communicate with customers on sensitive regulatory matters. Work as a strategic business partner with suppliers and business clients to develop and implement practical, timely, and effective business solutions to regulatory issues. Uphold the company's core values of Integrity, Innovation, Accountability, and Teamwork. Demonstrate behavior consistent with the company's Code of Ethics and Conduct. Report any quality problems or defects to management to ensure corrective action and prevent recurrence. Duties may be modified or assigned at any time to meet the needs of the business. Secondary Responsibilities: Support the Environmental Health and Safety (EHS) system by ensuring compliance with relevant regulations and standards. Assist in the development, implementation, and maintenance of EHS policies and procedures. Participate in EHS audits, inspections, and help address any identified issues. Support the Security and Privacy Program by ensuring compliance with data protection regulations and company policies. Assist in the development and implementation of security and privacy policies and procedures. Participate in s