Position SummaryThe Regulatory Affairs Contractor will provide regulatory support for medical device portfolio and business integration activities. The role will work closely with Regulatory Affairs and cross-functional partners to support global regulatory planning, product registrations, lifecycle management, and execution of integration-related regulatory activities.The ideal candidate will have hands-on medical device Regulatory Affairs experience and be comfortable independently managing multiple global regulatory deliverables in a fast-paced, cross-functional environment.Key ResponsibilitiesSupport regulatory activities associated with integration of medical device products and portfolios into existing business processes and systems.Develop, update, and maintain Global Regulatory Plans (GRPs) and associated regulatory documentation.Support global product registrations, renewals, license maintenance, and other market-specific regulatory requirements.Assess regulatory impact of product, manufacturing, labeling, supplier, site, and quality system changes.Support regulatory activities associated with legal manufacturer, manufacturing site, and quality system transitions, as applicable.Coordinate with regional Regulatory Affairs teams to identify country-specific requirements and execute regulatory actions necessary to maintain market access.Support EU MDR and other global regulatory lifecycle activities, including technical documentation updates, assessments, submissions, and notifications, as applicable.Review existing regulatory documentation, identify gaps, and coordinate actions required to support integration and ongoing compliance.Maintans, and deliverables and ensure activities are completed according to established timelines.Partner with Quality, Operations, R&D, Clinical, Supply Chain, and other cross-functional stakeholders to support integration activities.Identify and escalate regulatory risks, dependencies, and potential impacts to business or integration timelines.QualificationsBachelor’s degree ineering, Regulatory Affairs, or a related discipline.3–5+ years of medical device Regulatory Affairs experience preferred.Experience with global medical device registrations and lifecycle management.Working knowledge of FDA medical device requirements and EU MDR; experience with additional international markets preferred.Experience with regulatory change assessments, global regulatory planning, and/or business or product integration activities preferred.Ability to independently manage multiple regulatory deliverables and collaborate effectively across global teams.Strong organizational, written communication, and problem-solving skills.Preferred ExperienceExperience with Class II/III medical devices, global regulatory plans, EU MDR, regulatory change assessments, and integration or transition of established medical device portfolios is highly desirable.
29 days ago