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UnitedHealth Group is a healthcare and well‑being company dedicated to improving the health outcomes of millions worldwide. We work through UnitedHealthcare and Optum to build a better health system for all. Your contributions matter as they help transform health care for years to come. Make an impact with a team that shares your passion for helping others. Caring. Connecting. Growing together.
The Director of Regulatory Affairs will be a member of the Legal Team responsible for providing strategic counsel and support on regulatory and quality matters related to medical devices, including software and algorithms, and other digital health technologies. As a subject‑matter expert and leader, the Director will play a key role in developing and optimizing our regulatory affairs team, programs, and services. The Director will be responsible for maintaining and continuously improving enterprise regulatory affairs policies and procedures. Working closely with their team, legal and compliance colleagues, and business stakeholders, the Director will lead or support a wide range of regulatory activities, including regulatory assessments for new products and therapies, changes to existing products, and the development and execution of regulatory plans and strategies as required.
You will enjoy the flexibility to work remotely from anywhere within the U.S. As a full‑time hire located in the Minneapolis or Washington, D.C. area, you will be required to work in the office a minimum of four days per week.
Primary Responsibilities
- Lead and draft, review, and provide guidance on regulatory product assessments and other deliverables.
- Prepare regulatory plans and 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 across the enterprise and collaborate to successfully strategize and achieve regulatory and quality objectives.
- Review and provide guidance on labeling, including promotional labeling and advertisements.
- Collect, analyze, and disseminate 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.
- Develop and present educational and training material covering medical device and digital health regulatory affairs topics.
- Manage and participate in trade associations covering medical device topics and issues.
Required Qualifications
- 10+ years of experience in medical device regulatory affairs or a related field.
- Direct experience with Software as a Medical Device (SaMD), other digital health products, and accessories.
- Proven experience in preparing and submitting regulatory documentation, including filings to the FDA, EU MDR, and/or other global regulatory agencies.
- Experience with completing or supporting regulatory compliance activities such as site registrations, audits, post‑market vigilance reporting, and product recalls.
- Familiarity with 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.
- Demonstrated ability to successfully manage multiple regulatory projects, priorities, and people, if relevant.
Preferred Qualifications
- J.D., RAC Certification, ISO 13485 or other medical device auditor certification.
- Direct experience with AI/ML‑enabled medical devices or digital health technology.
- All remote employees will be required to adhere to UnitedHealth Group's Telecommuter Policy.
Pay is based on several factors including but not limited to local labor markets, education, work experience, certifications, etc. The salary for this role will range from $132,200 to $226,600 annually based on full‑time employment. In addition to your salary, we offer benefits such as a comprehensive benefits package, incentive and recognition programs, equity stock purchase, and 401(k) contribution (all benefits are subject to eligibility requirements).
Application Deadline: This posting will remain active for a minimum of 2 business days or until a sufficient candidate pool is collected. Job posting may close early due to volume of applicants.
At UnitedHealth Group, our mission is to help people live healthier lives and make the health system work better for everyone. We believe everyone—of every race, gender, sexuality, age, location, and income—deserves the opportunity to live their healthiest life. We are committed to mitigating our impact on the environment and delivering equitable care that addresses health disparities and improves health outcomes—an enterprise priority reflected in our mission.
UnitedHealth Group is an Equal Employment Opportunity employer under applicable law. Qualified applicants will receive consideration for employment without regard to race, national origin, religion, age, color, sex, sexual orientation, gender identity, disability, protected veteran status, or any other characteristic protected by local, state, or federal laws, rules, or regulations.
UnitedHealth Group is a drug‑free workplace. Candidates are required to pass a drug test before beginning employment.
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