Regulatory Affairs Specialist I

With a passion for lifeJoin our diverse teams of passionate people and a career that allows you to develop both personally and professionally. At Getinge we exist to make life-saving technology accessible for more people. To make a true difference for our customers - and to save more lives, we need team players, forward thinkers, and game changers.Are you looking for an inspiring career? You just found it.This role is open to US based candidatesCompensation depending upon locationJob OverviewThe Regulatory Affairs Specialist I will support global regulatory compliance activities for medical devices across Paragonix's product portfolio. This role will assist in preparing and maintaining regulatory submissions, coordinating documentation updates, and ensuring compliance with international and domestic regulatory requirements. The Specialist I will collaborate cross‐functionally to support sustaining engineering, quality systems, and product lifecycle activities while gaining foundational experience in global regulatory affairs.Job Responsibilities and Essential DutiesInternational RegistrationsLead preparation and maintenance of international registrations and renewals.Maintain Rimsys (regulatory management system) to ensure accuracy and completeness of registration and UDI records.* Labeling Coordination* Coordinate label updates and translation requests ensuring alignment with regulatory requirements.* Sustaining Support* Perform sustaining change assessments to evaluate regulatory impact of manufacturing, design, or documentation changes.Standards MonitoringMonitor changes in applicable standards and regulations and perform gap analyses as needed.Support tracking and communication of changes to cross functional teamsOtherSupport various external or internal regulatory requests under guidance from senior regulatory staff.Assist in drafting and updating regulatory procedures, work instructions, and related documentation.Support regulatory quality objectives and continuous improvement.Required QualificationsBachelor's degree in technical or scientific discipline; Master's degree or professional certification in Regulatory Affairs is a plus.Strong organizational and follow-up skills, as well as attention to detailAbility to work within a team and as an individual contributor in a fast-paced environmentAbility to multitask, prioritize work, and meet deadlines in timely manner.Ability to work collaboratively across different departments.Excellent communication and interpersonal skillsExcellent oral and written communication skills in English.