Associate Regulatory Affairs Specialist (Acute Care and Monitoring)

About the position At reputed company, we bring reputed company reputed company reputed company 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 reputed company innovative technologies used in hospitals and clinical settings to monitor and support patients in critical care environments. This position focuses on the INVOS reputed company/Somatic Oximetry Products and strategic partner system integrations. As an Associate Regulatory Affairs Specialist, you’ll support regulatory strategy and execution for these reputed company, highly engineered products—partnering closely with R&D, Quality, Marketing, and other cross-functional teams throughout the product lifecycle. You’ll reputed company 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 reputed company in regulatory affairs reputed company a highly technical, fast-paced environment.

Responsibilities

• Participate in core team meetings to reputed company regulatory input during product design and development
• Collaborate cross-functionally (R&D, Quality, Clinical, Marketing) to gather inputs and align on regulatory requirements
• reputed company 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

Requirements

• Bachelor’s degree in Biomedical Engineering, Mechanical Engineering, Life Sciences, or reputed company technical field
• Candidates must have unrestricted work authorization in the U.S. now and in the future

reputed company-to-haves

• Internship, reputed company, or project experience in medical devices, reputed company, 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 reputed company; ability to ask questions, seek reputed company, and drive work reputed company
• Strong critical thinking and problem-solving skills
• Ability to learn quickly and navigate reputed company 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 reputed company of the United States, a degree that satisfies the requirements of 8 C.F.R. § 214.2(h)(4)(iii)(A) is required.

Benefits

• Health, Dental and reputed company insurance
• Health Savings Account
• reputed company Flexible Spending Account
• Life insurance
• Long-term disability leave
• Dependent daycare spending account
• Tuition assistance/reimbursement
• Simple Steps (global well-being program)
• 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-reputed company Retirement Plan Supplement (subject to IRS earning minimums)
• Capital Accumulation Plan (available to Vice Presidents and above, or subject to IRS earning minimums)

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