Senior Associate General Counsel FDA Digital Health Telecommute US
Bring us your experience, your head for strategy, your strength with relationships and your eye for opportunity. In return we offer an unmatched place to grow and develop your career among a richly diverse group of businesses driven by the power and stability of a leading health care organization. Come help us heal and strengthen the health care system as you do your life's best work.(sm)
The Senior Associate General Counsel, FDA/Digital Health will support Optum serving as a subject matter expert advising on a wide array of issues, including the US Food, Drug and Cosmetic Act, new and existing regulations related to digital health technologies including FDA mobile medical app, clinical decision support software and medical device standards, FTC issues for mobile apps and online health programs, transactional issues, privacy and security, and other relevant state and federal laws and regulations.
Advise on requirements affecting all stages of a product's life cycle, including design, development, marketing, public relations, product launch and distribution, and related product FDA regulatory concerns. Act as a strategic legal partner to senior managers and in substantive legal areas on issues of FDA law, regulation and policy, government policy and enforcement, and in the compliance area.
You’ll enjoy the flexibility to telecommute* from anywhere within the U.S. as you take on some tough challenges.
Primary Responsibilities:
- Partner with compliance and regulatory affairs teams to assist and counsel in developing policies, procedures, product manuals, legal guidance documents, tools and training materials to ensure compliance with state and federal laws and regulations governing various digital health technologies.
- Monitor the external regulatory and enforcement environment to identify risks, performs day-to-day counseling and training of functional teams
- Update management on regulatory developments and communicate new developments to the affected business clients
- Supports the Company, as requested, in interactions with regulatory authorities
- Provide legal support for compliance investigations involving issues with the FDA
- Advise and counsel the Company on marketing and promotional matters
- Assist the Company in obtaining the FDA clearance and approval to market products
- Assist in complying with FDA post-market requirements
- Provide advice and counsel on various sales and marketing as well as other materials for dissemination relating to the Company and its potential products, as well as respond to requests from the RA/QA teams for reviewing product labeling and liability questions
- Manage outside FDA regulatory counsel
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:
- Juris Doctorate and Active License to practice law
- 8+ years’ related FDA Regulatory experience
- FDA healthcare regulatory subject matter expert with significant experience practicing at the intersection of technology and the law.
- Regulations, Investigational Device Exemptions, Investigational Review Boards, Marketing/Advertising/Promotion Regulations
- Management skills with the ability to lead cohesive and productive teams
- Driven to execute
- Process-minded and look for opportunities to streamline for improved efficiency and effectiveness
- If you need to enter a work site for any reason, you will be required to screen for symptoms using the ProtectWell mobile app, Interactive Voice Response (i.e., entering your symptoms via phone system) or a similar UnitedHealth Group-approved symptom screener. Employees must comply with any state and local masking orders. In addition, when in a UnitedHealth Group building, employees are expected to wear a mask in areas where physical distancing cannot be attained
Preferred Qualifications:
- Experience counselling clients regarding one or more of the following: digital multi-channel marketing and engagement, AI powered solutions or virtual care/digital clinical solutions
- Interpersonal skills with the ability to communicate with all levels of management through diplomacy and tact
- Success working on cross-functional teams within a corporate environment
UnitedHealth Group is working to create the health care system of tomorrow.
Already Fortune 6, we are totally focused on innovation and change. We work a little harder. We aim a little higher. We expect more from ourselves and each other. And at the end of the day, we're doing a lot of good.
Through our family of businesses and a lot of inspired individuals, we're building a high-performance health care system that works better for more people in more ways than ever. Now we're looking to reinforce our team with people who are decisive, brilliant - and built for speed.
Come to UnitedHealth Group, and share your ideas and your passion for doing more. We have roles that will fit your skills and knowledge. We have diverse opportunities that will fit your dreams.
Colorado Residents Only: The salary/hourly range for Colorado residents is $130,300 to $250,200 (add additional reference for sales and physicians). Pay is based on several factors including but not limited to education, work experience, certifications, etc. As of the date of this posting, In addition to your salary, UHG offers the following benefits for this position, subject to applicable eligibility requirements: Health, dental, and vision plans; wellness program; flexible spending accounts; paid parking or public transportation costs; 401(k) retirement plan; employee stock purchase plan; life insurance, short-term disability insurance, and long-term disability insurance; business travel accident insurance; Employee Assistance Program; PTO; and employee-paid critical illness and accident insurance.
All Telecommuters will be required to adhere to UnitedHealth Group’s Telecommuter Policy.
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.
Job Keywords: Senior Associate, General Counsel, FDA, Digital Health, Telecommute
