Sr. Legal Services Specialist - Regulatory Operations - Remote

at UnitedHealth Group in Chicago, Illinois, United States

Job Description

UnitedHealth Group is a health care and well-being company that’s dedicated to improving the health outcomes of millions around the world. We are comprised of two distinct and complementary businesses, UnitedHealthcare and Optum, working to build a better health system for all. Here, your contributions matter as they will help transform health care for years to come. Make an impact with a diverse team that shares your passion for helping others. Join us to start Caring. Connecting. Growing together.

Reporting to the Sr. Associate General Counsel responsible for digital health and medical device matters, this Sr. Legal Services Specialist – Paralegal/Regulatory Operations will be part of a collaborative Legal Team supporting UnitedHealth Group’s technology operations and regulated businesses and businesses with regulated products, such as software medical devices. Successful candidates will have experience supporting regulated products or businesses and experience working in matrixed environments.

You’ll enjoy the flexibility of a remote or hybrid working arrangement from any flagship office of UnitedHealth Group in the U.S. (e.g., Eden Prairie, MN, New York, Washington DC) as you take on some tough challenges.

Primary 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, including coordination, training, developing, and implementing plans, and providing input to systems designs

+ Research and analyze regulations, guidance documents, standards, and industry practice on matters related to digital health technology as applicable to the Legal team’s efforts

+ Help draft and administer internal procedures, policies, regulatory and/or quality assessments and guidance documents to ensure standard processes for regulated products and activities across the enterprise

+ Assist Legal and QMRA Team with managing critical legal and regulatory documents (quality contracts, legal advice, etc.), communications and files

+ Support initial screenings or intake process(es) to streamline inquiries, assessments, and reviews on health technology products, ad/promo materials, and related matters

+ 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

You’ll be rewarded and recognized for your performance in an environment that will challenge you and give you clear direction on what it takes to succeed in your role as well as provide development for other roles you may be interested in.

Required Qualifications:

+ 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 (or other regulated agency/body) and regulated products and manufacturing activities like medical devices (including software), 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 (e.g., FDA databases)

+ Demonstrated verbal and written communication skills including presentations

+ Demonstrated ability to work well under pressure in a dynamic and highly matrixed environment and can be flexible as needed to meet changing needs

+ Demonstrated attention to detail, accuracy, and confidentiality

+ Demonstrated organizational skills, highly detail oriented, and effective task and project management skills

Preferred Qualifications:

+ Experience with document management systems used in the medical device or pharmaceutical industry (Dot Compliance, Agile, SAP, Documentum or other)

+ Expert with Microsoft Office Applications, Word, PowerPoint, Excel and other office applications (iManage)

*All employees working remotely will be required to adhere to UnitedHealth Group’s Telecommuter Policy

California, Colorado, Connecticut, Hawaii, Nevada, New York, New Jersey, Rhode Island, Washington or Washington, D.C. Residents Only: The salary range for this role is $70,200 to $137,800 annually. Pay is based on several factors including but not limited to local labor markets, education, work experience, certifications, etc. UnitedHealth Group complies with all minimum wage laws as applicable. In addition to your salary, UnitedHealth Group offers benefits such as, a comprehensive benefits package, incentive and recognition programs, equity stock purchase and 401k contribution (all benefits are subject to eligibility requirements). No matter where or when you begin a career with UnitedHealth Group, you’ll find a far-reaching choice of benefits and incentives.

Application Deadline: This will be posted for a minimum of 2 business days or until a sufficient candidate pool has been collected. Job posting may come down 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. Today, however, there are still far too many barriers to good health which are disproportionately experienced by people of color, historically marginalized groups and those with lower incomes. We are committed to mitigating our impact on the environment and enabling and delivering equitable care that addresses health disparities and improves health outcomes – an enterprise priority reflected in our mission.

Diversity creates a healthier atmosphere: UnitedHealth Group is an Equal Employment Opportunity/Affirmative Action employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, age, national origin, protected veteran status, disability status, sexual orientation, gender identity or expression, marital status, genetic information, or any other characteristic protected by law.

UnitedHealth Group is a drug-free workplace. Candidates are required to pass a drug test before beginning employment.