Hiring: Director of Regulatory Affairs - Remote Company: UnitedHealth Group Location: Eden Prairie, MN Job Posted Time: 2026-09-03 10:46:16 Employment Type: Full-time Target Skills & Keywords : Regulatory Compliance About the job Experience: •10+ years of experience in medical device regulatory affairs or related field Required Skills: •Lead and draft, review, and provide guidance on regulatory product assessments and other deliverables •Prepare regulatory plans/strategies and provide ongoing support as needed for various regulatory, quality, and compliance activities •Provide expert and practical regulatory advice and support on regulatory and quality requirements throughout a project or product lifecycle •Effectively communicate complex regulatory topics to a broad audience in our enterprise and collaborate across the enterprise to successfully strategize and achieve regulatory and quality objectives •Review and provide guidance on labeling including promotional labeling and advertisements (promotional communications) •Collecting, analyzing, and disseminating regulatory intelligence on new and changing requirements, policies, and guidelines •Support regulatory compliance activities, including manufacturing site registration, audits, inspections, post-market vigilance reporting, and product recalls •Prepare or support regulatory submissions and filings as needed Qualifications: •Proven experience in preparing and submitting regulatory documentation including filings to the FDA, EU MDR, and/or other global regulatory agencies •Demonstrated familiarity using and/or managing electronic quality management systems •Proven expertise and working knowledge of applicable regulations, standards and guidance for medical devices (FDA, QSMR, SaMD, ISO 13485, ISO 14971, IEC 62304, and other global regulatory requirements and quality standards) •Proven ability to learn and adapt to provide strategic regulatory advice in an evolving industry •Proven excellent written and oral communication, interpersonal, and problem-solving skills to effectively interact with others, including cross-functional teams and regulatory agencies, and address regulatory matters •Demonstrated ability to successfully manage multiple regulatory projects, priorities, and people, if relevant •J.D., RAC Certification, ISO 13485 or other medical device auditor certification •Direct experience with Software as a Medical Devices (SaMD), other Digital Health products, and accessories •Direct experience with AI/ML-enabled medical devices or digital health technology •All employees working remotely will be required to adhere to UnitedHealth Group's Telecommuter Policy. Compensation: •$134,600 - $230,800 / year •Flexible work environment (work from home / hybrid options) •Competitive benefits and rewards package Interested candidates, please apply directly through the job posting on company's career page or try via AI auto apply on this platform. Don't miss this opportunity to join a forward-thinking team!