Job Description 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 Senior Regulatory Affairs (RA) Specialist supports the regulatory and product registration activities of the company. This RA Specialist role requires a professional who will work closely with high priority regulatory activities such as U.S. premarket submissions, product registration in MDSAP countries, and other primary international market registrations. You will provide regulatory feedback in order to facilitate the launch of new products globally and work with the design control teams to assess for regulatory impact of product changes. You will provide technical guidance to cross functional teams for submission preparation and interaction with regulatory agencies. Responsibilities Coordinate, author, and prepare regulatory submissions, including 510(k) premarket notifications, Canadian license applications, international submission packages and/or other documentation required for worldwide registration/licensure of products. Work as a strategic business partner with business clients to proactively develop and implement practical, compliant regulatory plans, and also timely, effective business solutions to quality and regulatory issues. Respond to regulatory agency requests and obtain necessary premarket clearances and/or approvals from domestic and international regulatory agencies. Provide general support to the RA/QA department in regulatory-related matters. Communicate with external agencies including the US FDA, Health Canada, and other health authorities with which the department interacts. Act as regulatory SME in product development cross-functional teams and other cross-functional activities as assigned. Evaluate and approve proposed changes to products and controlled documents; develop, approve, and implement global regulatory action plans based on these changes. Maintain regulatory information in Rimsys, regulatory information management system, to ensure product selling status is in regulatory compliance with applicable local and regional country requirements. Review and approve labeling for compliance to standards, guidelines, regulations, and regulatory approvals/clearances. Provide assistance and expertise during regulatory inspections or audits. Create and maintain regulatory documents and records, including summaries of such regulatory affairs activities and reports to management. Continue to enhance internal regulatory procedures and processes. Create and revise procedures as needed and provide training for these updates. This position requires the ability to take initiative and effectively communicate cross-functionally, both externally and at all levels of the organization. Uphold the Company's core values of Integrity, Innovation, Accountability, and Teamwork. Demonstrate behavior consistent with the Company's Code of Ethics and Conduct. It is the responsibility of every Spacelabs Healthcare employee to report to their manager or a member of senior management any quality problems or defects in order for corrective action to be implemented and to avoid the recurrence of the problem. Duties may be modified or assigned at any time to meet the needs of the business. Recommend and maintain quality programs and systems to support corporate quality policy, regulatory requirements, and quality objectives. Qualifications Bachelor's Degree is required. A degree with technical / engineering background is preferred. A minimum of 8+ years in medical device or related field and 5+ years of