At Medtronic, we bring bold ideas forward with speed and decisiveness to put patients first in everything we do. In-person exchanges are invaluable to our work. We’re working a minimum of 4 days a week onsite as part of our commitment to fostering a culture of professional growth and cross-functional collaboration as we work together to engineer the extraordinary. This role is onsite 4 days per week in Lafayette, Colorado. In our Acute Care & Monitoring (ACM) Operating Unit, teams develop innovative technologies used in hospitals and clinical settings to monitor and support patients in critical care environments. This position focuses on the INVOS Cerebral/ Somatic Oximetry Products and strategic partner system integrations. As an Associate Regulatory Affairs Specialist, you’ll support regulatory strategy and execution for these complex, highly engineered products—partnering closely with R&D, Quality, Marketing, and other cross-functional teams throughout the product lifecycle. You’ll gain exposure to how products move from early design concepts through regulatory submission and commercialization, helping ensure compliance while enabling innovation. This is an ideal opportunity for someone early in their career who is excited to learn, collaborate, and build a strong foundation in regulatory affairs within a highly technical, fast-paced environment. In this role, you will:Participate in core team meetings to provide regulatory input during product design and development. Collaborate cross-functionally (R&D, Quality, Clinical, Marketing) to gather inputs and align on regulatory requirements. Develop regulatory strategies for U.S., EU, and global markets. Contribute to regulatory submissions (e.g., 510(k)), letters to file, and supporting documentation. Compile and coordinate materials for submissions, renewals, and product registrations. Monitor regulatory requirements and ensure alignment throughout the product lifecycleSupport audits, inspections, and internal documentation readiness. Help track and maintain regulatory deliverables, timelines, and documentation systems. Recommend updates to labeling, manufacturing, and clinical documentation to maintain compliance. Minimum Requirements (must have)Bachelor’s degree in Biomedical Engineering, Mechanical Engineering, Life Sciences, or related technical field. Candidates must have unrestricted work authorization in the U.S. now and in the future. Preferred Qualifications. Internship, co-op, or project experience in medical devices, healthcare, or a regulated industry. Exposure to regulatory affairs, quality systems, or product development processes. Familiarity with FDA (e.g., 510(k)) or EU MDR concepts (coursework or academic exposure acceptable)Demonstrated ability to manage multiple tasks, meet deadlines, and stay organized. Proactive mindset; ability to ask questions, seek clarity, and drive work forward. Strong critical thinking and problem-solving skills. Ability to learn quickly and navigate complex technical and regulatory topics. Strong communication and collaboration skills across cross-functional teams. Ability to influence and collaborate without direct authority. Comfort working in a fast-paced, evolving environment where not everything is “black and white”Candidates local to Lafayette, CO preferred. For Baccalaureate degrees earned outside of the United States, a degree that satisfies the requirements of 8 C. F. R. § 214.2(h)(4)(iii)(A) is required. Physical Job Requirements. The above statements are intended to describe the general nature and level of work being performed by employees assigned to this position, but they are not an exhaustive list of all the required responsibilities and skills of this position.