Sr. Legal Services Specialist - Regulatory Operations - Remote

$70,200 - $137,800/Yr

UnitedHealth Group - Chicago, IL

Full-time - Mid Level

Remote - Chicago, IL

Insurance Carriers and Related Activities

About the position

UnitedHealth Group is a health care and well-being company dedicated to improving health outcomes globally. The Sr. Legal Services Specialist - Paralegal/Regulatory Operations will be part of a collaborative Legal Team that supports UnitedHealth Group's technology operations and regulated businesses, particularly those involving regulated products like software medical devices. This role is crucial in ensuring compliance with legal and regulatory standards while contributing to the development of innovative health solutions. The successful candidate will report to the Sr. Associate General Counsel responsible for digital health and medical device matters, and will work closely with various stakeholders including Legal, Quality Management and Regulatory Affairs (QMRA), and Compliance. The position offers flexibility with remote or hybrid working arrangements from any flagship office in the U.S. (e.g., Eden Prairie, MN, New York, Washington DC).

Responsibilities

• Provide day-to-day legal services support including leading or assisting as the paralegal/regulatory operations on special projects from the Legal Team
• Work closely with Legal, Quality Management and Regulatory Affairs (QMRA), Compliance and other cross-business and functional stakeholders on activities related to enterprise-wide regulatory and quality management systems
• Research and analyze regulations, guidance documents, standards, and industry practice on matters related to digital health technology
• Help draft and administer internal procedures, policies, regulatory and/or quality assessments and guidance documents
• Assist Legal and QMRA Team with managing critical legal and regulatory documents, communications and files
• Support initial screenings or intake process(es) to streamline inquiries, assessments, and reviews on health technology products
• Support Legal with marketing and promotional material reviews
• Assist with tracking, monitoring, and reporting of metrics as needed
• Assist Legal Team with the creation and preparation of meeting materials, presentations, PowerPoints, trainings, and other documentations
• Monitor and analyze the impact of new or changing regulations, enforcement actions and other changes that impact product regulation
• Contribute to dissemination of regulatory intelligence on topics of interest

Requirements

• 2+ years of experience in a paralegal or other supporting role at either a legal firm and/or corporate setting in a regulated industry such as healthcare, med device, drugs, or similar
• Experience with federal regulations and regulatory agencies like the FDA and regulated products and manufacturing activities like medical devices, drugs and/or biologics
• Experience with being proactive in identifying and resolving everyday and project problems
• Demonstrated understanding of state and federal administrative and IT applications for example, policies, submissions, registrations & listings, and other systems
• Demonstrated verbal and written communication skills including presentations
• Demonstrated ability to work well under pressure in a dynamic and highly matrixed environment
• Demonstrated attention to detail, accuracy, and confidentiality
• Demonstrated organizational skills, highly detail oriented, and effective task and project management skills

Nice-to-haves

• Experience with document management systems used in the medical device or pharmaceutical industry
• Expert with Microsoft Office Applications, Word, PowerPoint, Excel and other office applications

Benefits

• Comprehensive benefits package
• Incentive and recognition programs
• Equity stock purchase
• 401k contribution