Regulatory and Legal Operations Manager

Flatiron Health is hiring a Regulatory and Legal Operations Manager to manage its regulatory program and ensure its point-of-care products meet and maintain regulatory and certification requirements. The role also supports daily legal operations, contract lifecycle management, and projects that improve the Legal team’s efficiency and effectiveness.

Responsibilities

• Develop and execute against the regulatory program roadmap to ensure regulatory requirements are timely and effectively implemented
• Serve as primary liaison between legal and business and technical stakeholders to translate regulatory requirements into actionable plans
• Drive accountability with teams to ensure timely completion of regulatory requirements
• Compile and submit regulatory reporting requirements, coordinating across Product, Legal, and external regulatory certification bodies
• Manage and refine regulatory program processes that support compliance with industry regulations
• Continuously evaluate and improve processes to ensure efficiency and effectiveness, incorporating feedback from technical and legal teams
• Manage training programs to educate relevant teams on regulatory requirements, policies, and best practices and ensure that teams understand how regulatory compliance impacts their work
• Ensure Flatiron’s adherence to all regulatory obligations
• Monitor the overall compliance of Flatiron’s regulated products and services
• Supports regulatory incidents or corrective action plans that may impact regulatory compliance, as needed
• Maintain good standing with federal regulatory certification programs, including the ONC certification program for Health IT developers
• Participate in relevant regulatory communities/industries; gathers regulatory policy intelligence and analyzes changes in the regulatory environment to inform decision making
• Drive contract lifecycle management (CLM) to ensure the timely execution of commercial agreements
• Support ongoing maintenance of CLM tool, Ironclad, across legal and all business units, configuring system and workflows to meet stakeholder needs
• Maintain contracting process documentation and provide end user training for new sales representatives and account managers
• Route contracts for signature as needed and ensure all executed agreements are correctly archived
• Establish reporting to assess CLM KPIs and drive data-driven process improvement
• Identify opportunities and lead projects to enable greater efficiency across the Legal team
• Identify and implement tools (including AI functionality) to streamline practices, as well as manage design, rollout, and training for new systems
• Assist in developing legal and regulatory knowledge management systems and practices to preserve and deploy information assets (e.g. organization of Legal team drive and document management processes, etc.)

Preferred

• Knowledge of the following healthcare regulatory programs: Office of the National Coordinator for Health Information Technology (ONC)'s Health IT certification program and certain CMS regulatory programs (e.g., MIPS)
• Experience developing, implementing, and using legal department technology solutions, e.g., Ironclad/Contract Lifecycle Management software and Docusign e-signature
• Experience identifying, implementing, or leveraging AI tools or AI agents to streamline and scale legal or regulatory processes (e.g., Credal, Claude Cowork, Gemini)
• ONC Health IT Certification
• CMS Regulatory Programs
• MIPS
• Legal Technology Solutions
• Contract Lifecycle Management Software
• Ironclad
• E-Signature Software
• DocuSign
• Agents
• Credal
• Claude Cowork
• Gemini
• Legal Process Optimization
• Regulatory Process Optimization

Benefits

• Flexible work hours and flexible paid time off
• 401(k) contribution
• Financial health resources, including 1:1 financial advice
• Mental well-being tools and services
• Parental benefits and policies, including family-building care and generous leave
• Path to parenthood programs supporting fertility, adoption and surrogacy
• Travel support for safe healthcare services
• This role can be based remotely or in the NYC or Durham office. For NY and Durham candidates, the defined work location includes work from home and 3 office days set by you and your team.

Company

• Oncology real-world data and AI insights platform
• New York, New York, USA
• https://flatiron.com/
• Founded in 2012
• 1001-5000 employees

Qualifications

• You have 3-5 years of experience in operations, program management, or project management in a highly regulated environment (ideally health tech or healthcare)
• You have familiarity with software development and contracting processes
• You have robust problem solving and project management skills and a bias for action with demonstrated success executing projects with multiple dependencies and maintaining accountability and relationships with stakeholders
• You demonstrate autonomy in decision-making and execution while maintaining open communication with stakeholders, ensuring collaboration and seeking input when necessary
• You recognize and escalate issues appropriately to avoid working in isolation and to address challenges efficiently
• You have the ability to identify what's important and effectively prioritize competing workstreams
• You have excellent communications skills, with the ability to synthesize, simplify, and explain complex topics to different cross-functional stakeholders
• You have demonstrated ability to learn quickly in a fast-paced environment
• You have a high degree of comfort with ambiguity and are able to quickly develop hypotheses with limited information
• Knowledge of the following healthcare regulatory programs: Office of the National Coordinator for Health Information Technology (ONC)'s Health IT certification program and certain CMS regulatory programs (e.g., MIPS)
• Experience developing, implementing, and using legal department technology solutions, e.g., Ironclad/Contract Lifecycle Management software and Docusign e-signature
• Experience identifying, implementing, or leveraging AI tools or AI agents to streamline and scale legal or regulatory processes (e.g., Credal, Claude Cowork, Gemini)
• You have 3-5 years of experience in operations, program management, or project management in a highly regulated environment (ideally health tech or healthcare).

Required skills

• CMS MIPS, Claude Cowork, Contracting Processes, Credal, DocuSign, Gemini, Ironclad, ONC Health IT Certification Program, Software Development

Preferred skills

• Project Management

Experience

• 3-5 years