About This Role

This position is part of the Legal Department and will support the business globally. The position involves handling major projects, transactions or matters under the supervision of Legal Director, Regulatory, Marketing and Employment and has principal responsibility for planning and directing more discrete projects, transactions, or matters. Serves relevant business leadership and other legal department members as a key advisor in defined areas of medical device regulatory law.

Responsibilities:

The candidate selected for this role will:

• Provide legal guidance and counseling to business and functional teams (such as sales and marketing, regulatory affairs, medical affairs, government affairs, patient access, clinical, quality, R&D, finance, and others).
• Proactively identify and manage regulatory legal risks for complex US or global issues and develop and approve action plans.
• Collaborate with legal colleagues and cross-functional teams to ensure appropriate expertise is applied to specialized issues, including regulatory strategy, product development and product approvals; advertising and promotion; post-approval compliance; FDA enforcement actions and litigation; due diligence reviews and transactional support.
• Train business on legal topics including Anti-Kickback Statute and safe harbors, good promotional practices, reimbursement, and other relevant regulatory issues.
• Support for M&A projects through due diligence review of regulatory issues and integration work.
• Provide support to the organizations lead by the Chief Medical Officer, Chief Scientific Officer and EVP, Product Innovation with respect to a wide variety of legal issues including contracts, technology transfers, regulatory considerations, general operating issues, and international complexities.
• Provide support to the Commercial group on government reimbursement issues.
• Responsible for interpreting, negotiating, and drafting clinical trial agreements and a variety of other agreements related to interactions with healthcare professionals/institutions, as well as handling other legal projects or matters as assigned.

About You:

Education and Experience:

• JD and licensed in good standing to practice law in at least one state and one federal jurisdiction within the United States.
• Minimum of 5-8 years of relevant professional experience with a mix of work in a law firm, government agency, and/or comparable corporate environment.
• Experience in the device industry and/or similar healthcare regulatory experience.
• Working knowledge in one or more of the following areas: Anti-Kickback Statute and False Claims Act, FDA promotional and other regulatory requirements from FDA, CMS, DOJ, and various state regulators, and industry codes governing interactions with healthcare professionals.
• Experience with Government Reimbursement preferred but not required.

Essential Skills:

• Strong business and personal ethics and integrity
• Demonstrated experience as a valued business and regulatory lawyer and genuine team player.
• Proven experience with counseling business clients on regulatory issues related to the Federal Food, Drug, and Cosmetic Act.
• Dynamic and resilient individual with the demonstrated ability and confidence to make decisions and influence senior management, persuade, and build consensus across the business and functions.
• Demonstrated ability to prioritize workload, meet deadlines and work with minimal supervision in a team and matrix environment, sound judgment and strong attention to detail.
• Excellent written and oral communication skills.
• Experience in drafting and negotiating complex commercial, clinical trial and healthcare provider agreements.

Position Details:

• Type of role: Permanent
• Schedule:Full-Time
• Location: Remote
• Compensation & Benefits: Very competitive within the current market and commensurate with experience

What's In It For You

This is a regular full-time position with competitive compensation package, excellent benefits including medical, dental, and vision insurances (all of which start on your first day), health savings account employer contributions (when enrolled in high deductible medical plan), cafeteria plan pre-taxed benefits (FSA, dependent care FSA, commute reimbursement accounts), travel reimbursement for medical care, noncontributory basic life insurance & short/ long term disability. Additionally, we offer:

• emotional health support for you and your loved ones
• legal / financial / identity theft/ pet and child referral assistance
• paid parental leave, paid holidays, travel assistance for personal trips and PTO!

iRhythm also provides additional benefits including 401(k) (with company match), an Employee Stock Purchase Plan, pet insurance discount, unlimited amount of Linked In Learning classes and so much more!

FLSA Status: Exempt

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