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Full-Time

Senior Regulatory Counsel

Confirmed live in the last 24 hours

iRhythm Technologies

iRhythm Technologies

1,001-5,000 employees

Ambulatory cardiac monitoring with wearable biosensors

Data & Analytics

Compensation Overview

$182.9k - $268.4kAnnually

Senior, Expert

Remote in USA

Category
Legal
Legal & Compliance
Requirements
  • 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 Anti-Kickback Statute and False Claims Act, FDA promotional and other regulatory requirements from FDA, CMS, DOJ, and various state regulators
  • Experience with Government Reimbursement preferred but not required
Responsibilities
  • Provide legal guidance and counseling to business and functional teams
  • Proactively identify and manage regulatory legal risks for complex US or global issues
  • Collaborate with legal colleagues and cross-functional teams to ensure appropriate expertise is applied to specialized issues
  • 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
  • Provide support to the Commercial group on government reimbursement issues
  • Responsible for interpreting, negotiating, and drafting clinical trial agreements and other agreements related to interactions with healthcare professionals/institutions

The Zio service by iRhythm Technologies provides a next-generation ambulatory cardiac monitoring solution with single-use monitors, offering continuous and accurate data for up to 14 days. The technology utilizes wearable biosensors, cloud-based data analytics, and proprietary algorithms to distill data from millions of heartbeats into clinically actionable information.

Company Stage

IPO

Total Funding

$1.2B

Headquarters

San Francisco, California

Founded

2006

Growth & Insights
Headcount

6 month growth

4%

1 year growth

12%

2 year growth

32%