Regulatory and Legal Operations Manager

New
F
Flatiron HealthHealth tech
Remote - USFull-TimeManager
Salary114,400 - 157,300 USD per year
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Job Details

Experience
3-5 years of experience in operations, program management, or project management in a highly regulated environment.
Required Skills
Project Management

Requirements

  • Have 3-5 years of experience in operations, program management, or project management in a highly regulated environment.
  • Bring experience in health tech or healthcare, ideally.
  • Have familiarity with software development and contracting processes.
  • Demonstrate project management and problem-solving skills, including executing projects with multiple dependencies.
  • Be able to maintain accountability and working relationships with stakeholders.
  • Be able to prioritize competing workstreams and learn quickly in a fast-paced environment.
  • Be comfortable working with ambiguity and developing hypotheses with limited information.
  • Knowledge of ONC Health IT certification and CMS regulatory programs such as MIPS is a plus.
  • Experience with legal department technology, such as Ironclad, contract lifecycle management software, or DocuSign, is a plus.
  • Experience using AI tools or agents to streamline legal or regulatory processes is a plus.

Responsibilities

  • Develop and execute the regulatory program roadmap to implement requirements.
  • Translate regulatory requirements into actionable plans with legal, business, and technical stakeholders.
  • Coordinate regulatory reporting across Product, Legal, and external certification bodies.
  • Manage and improve regulatory program processes, training, and compliance monitoring.
  • Support regulatory incidents and corrective action plans, and maintain standing with federal certification programs, including ONC.
  • Monitor regulatory policy changes and analyze their implications for decision-making.
  • Maintain the Ironclad contract lifecycle management tool, including configuring systems and workflows.
  • Maintain contracting process documentation, train end users, route contracts for signature, and archive executed agreements.
  • Establish CLM KPI reporting and lead data-driven process improvements.
  • Identify and implement tools and knowledge management practices to improve Legal team efficiency.
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114,400 - 157,300 USD per year
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