Sr. Legal Services Specialist – Regulatory Operations – Remote

Title: Sr. Legal Services Specialist – Regulatory Operations – Remote

Location: Minnetonka MN US

Full Time
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

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)

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.