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Sr Legal Services Specialist /Regulatory Ops (FDA Law)

$70,200- $137,800/ year
Posted Jun 09
Full Time
HybridMinnetonka, Minnesota

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 Paralegal/Sr. Legal Services Specialist 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 to work remotely * from anywhere within the U.S. as you take on some tough challenges. 

 

Primary Responsibilities:

  • Provide day-to-day paralegal and legal services support including leading or assisting 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 Qualification:

  • 2+ years of experience as a paralegal in or supporting a regulated industry 

 

Preferred Qualifications:

  • Regulatory Affairs, Quality Management, medical devices (including software) or equivalent experience in a regulated industry
  • Experience with Dot Compliance, Agile, SAP, Documentum or other document management systems used in the medical device or pharmaceutical industry
  • Expert with Microsoft Office Applications, Word, PowerPoint, Excel and other 
  • Proven solid verbal and written communication skills 
  • Proven attention to detail, accuracy, and confidentiality 
  • Proven organizational skills, highly detail oriented, and effective task and project management skills
  • Proven self-motivated and proactive in identifying and resolving everyday and project problems, team player and strong work ethic 
  • Proven ability to work well under pressure in a dynamic and highly matrixed environment and can be flexible as needed to meet changing needs 

        

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

 

California, Colorado, Connecticut, Hawaii, Nevada, New Jersey, New York, Rhode Island, or Washington 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.