Regulatory and Legal Operations Manager

Flatiron Health•New York, NY

7d•Hybrid

About The Position

This role sits at the intersection of technology, law, and healthcare. Reporting to the Director of Legal and Regulatory Operations, the Regulatory and Legal Operations Manager manages Flatiron’s regulatory program and partners with Legal, technical, and other business stakeholders to ensure Flatiron’s point-of-care products meet and maintain regulatory and certification requirements. The role also drives day-to-day legal operations and strategic projects to improve the Legal team’s efficiency and effectiveness.

Requirements

3–5 years of experience in operations, program management, or project management in a highly regulated environment, ideally health tech or healthcare.
Familiarity with software development and contracting processes, and willingness to learn the legal and regulatory landscape affecting the company’s products and services.
Strong problem-solving and project-management skills, with a bias for action and demonstrated success executing projects with multiple dependencies while maintaining stakeholder accountability and relationships.
Ability to make decisions and execute autonomously while communicating openly, collaborating, seeking input when needed, and escalating issues appropriately.
Ability to identify priorities and manage competing workstreams effectively.
Excellent communication skills, including the ability to synthesize, simplify, and explain complex topics to cross-functional stakeholders.
Ability to learn quickly in a fast-paced environment.
Comfort with ambiguity and ability to develop hypotheses quickly with limited information.

Nice To Haves

Knowledge of healthcare regulatory programs, including the ONC Health IT certification program and certain CMS regulatory programs such as MIPS.
Experience developing, implementing, and using legal department technology solutions, such as Ironclad or other contract lifecycle management software and DocuSign e-signature.
Experience identifying, implementing, or leveraging AI tools or agents to streamline and scale legal or regulatory processes, such as Credal, Claude Cowork, or Gemini.

Responsibilities

Develop and execute the regulatory program roadmap to ensure regulatory requirements are implemented effectively and on time.
Serve as the primary liaison between Legal and business and technical stakeholders, translating regulatory requirements into actionable plans.
Drive accountability across teams to ensure timely completion of regulatory requirements.
Compile and submit regulatory reports, coordinating with Product, Legal, and external regulatory certification bodies.
Manage and refine regulatory program processes that support compliance with industry regulations.
Continuously evaluate and improve processes for efficiency and effectiveness, incorporating feedback from technical and legal teams.
Manage training programs that educate relevant teams on regulatory requirements, policies, and best practices, and help teams understand how compliance affects their work.
Ensure Flatiron’s adherence to regulatory obligations and monitor compliance of its regulated products and services.
Support regulatory incidents or corrective action plans that may affect 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 and industries, gather regulatory policy intelligence, and analyze changes in the regulatory environment to inform decisions.
Drive contract lifecycle management to support timely execution of commercial agreements.
Support ongoing maintenance of the Ironclad CLM tool across Legal and business units, configuring the 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 executed agreements are correctly archived.
Establish reporting to assess CLM KPIs and drive data-informed process improvement.
Identify opportunities and lead projects to improve Legal team efficiency.
Identify and implement tools, including AI functionality, to streamline practices; manage system design, rollout, and training.
Assist in developing legal and regulatory knowledge-management systems and practices to preserve and deploy information assets, including Legal team drive organization and document-management processes.

Benefits

Flexible work hours and flexible paid time off.
Comprehensive compensation package.
401(k) contribution.
Financial health resources, including one-to-one 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.
Continuous learning support.
Diversity in the workplace.