Associate Regulatory Affairs Specialist (Acute Care and Monitoring)

Associate Regulatory Affairs Specialist (Acute Care and Monitoring) Location: Lafayette, Colorado, United States of America We anticipate the application window for this opening will close on - 27 May 2026 At Medtronic you can begin a life-long career of exploration and innovation, while helping champion healthcare access and equity for all. You’ll lead with purpose, breaking down barriers to innovation in a more connected, compassionate world. A Day in the Life 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 lifecycle Support 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. The physical demands described within the Responsibilities section of this job description are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. For Office Roles: While performing the duties of this job, the employee is regularly required to be independently mobile. The employee is also required to interact with a computer, and communicate with peers and co-workers. Contact your manager or local HR to understand the Work Conditions and Physical requirements that may be specific to each role. U.S. Work Authorization & Sponsorship At Medtronic, we are committed to fostering an environment where employees can thrive and make a meaningful impact. In alignment with our enterprise-wide workforce planning approach, U.S. work authorization sponsorship (H-1B, TN, J, etc.) is offered exclusively for Principal-level roles and above, where specialized expertise aligns with long-term business needs. Roles below the Principal level require candidates to possess unrestricted U.S. work authorization at the time of hire and for the duration of employment. Join us in our mission to alleviate pain, restore health, and extend life—where your unique background and perspective are valued. Benefits & Compensation Medtronic offers a competitive Salary and flexible Benefits Package Salary ranges for U.S (excl. PR) locations (USD):$60,800.00 - $91,200.00 This position is eligible for a short-term incentive called the Medtronic Incentive Plan (MIP). The base salary range is applicable across the United States, excluding Puerto Rico and specific locations in California. The offered rate complies with federal and local regulations and may vary based on factors such as experience, certification/education, market conditions, and location. Compensation and benefits information pertains solely to candidates hired within the United States (local market compensation and benefits will apply for others). The following benefits and additional compensation are available to those regular employees who work 20+ hours per week: Health, Dental and vision insurance,Health Savings Account,Healthcare Flexible Spending Account,Life insurance, Long-term disability leave,Dependent daycare spending account,Tuition assistance/reimbursement, andSimple Steps (global well-being program). The following benefits and additional compensation are available to all regular employees:Incentive plans, 401(k) plan plus employer contribution and match,Short-term disability,Paid time off,Paid holidays,Employee Stock Purchase Plan,Employee Assistance Program,Non-qualified Retirement Plan Supplement (subject to IRS earning minimums), andCapital Accumulation Plan (available to Vice Presidents and above, or subject to IRS earning minimums). Regular employees are those who are not temporary, such as interns.  Temporary employees are eligible for paid sick time, as required under applicable state law, and the Employee Stock Purchase Plan. Please note some of the above benefits may not apply to workers in Puerto Rico. Further details are available at the link below: Medtronic benefits and compensation plans About Medtronic We lead global healthcare technology and boldly attack the most challenging health problems facing humanity by searching out and finding solutions. Our Mission — to alleviate pain, restore health, and extend life — unites a global team of 95,000+ passionate people. We are engineers at heart— putting ambitious ideas to work to generate real solutions for real people. From the R&D lab, to the factory floor, to the conference room, every one of us experiments, creates, builds, improves and solves. We have the talent, diverse perspectives, and guts to engineer the extraordinary. Learn more about our business, mission, and our commitment to diversity here. It is the policy of Medtronic to provide equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by federal, state or local law. In addition, Medtronic will provide reasonable accommodations for qualified individuals with disabilities. If you are applying to perform work for Medtronic, Inc. (“Medtronic”) in any position which will involve performing at least two (2) hours of work on average each week within the unincorporated areas of Los Angeles County, you can findherea list of all material job duties of the specific job position which Medtronic reasonably believes that criminal history may have a direct, adverse and negative relationship potentially resulting in the withdrawal of a conditional offer of employment. Medtronic will consider for employment qualified job applicants with arrest or conviction records in accordance with the Los Angeles County Fair Chance Ordinance for Employers and the California Fair Chance Act.