Regulatory and Legal Operations Manager
Flatiron Health · Durham
Reimagine the infrastructure of cancer care within a community that values integrity, inspires growth, and is uniquely positioned to create a more modern, connected oncology ecosystem.
We’re looking for a Regulatory and Legal Operations Manager to help us accomplish our mission to improve and extend lives by learning from the experience of every person with cancer. Are you ready to be the next changemaker in cancer care?
What you’ll do
This role sits at the intersection of technology, law, and healthcare. Reporting to the Director of Legal and Regulatory Operations, you will manage Flatiron’s regulatory program and partner with Legal, technical and other business stakeholders to ensure Flatiron’s point of care products meet and maintain regulatory and certification requirements. You will also play a key role in driving daily legal operations and strategic projects to improve overall Legal team efficiency and effectiveness. Core job responsibilities includes:
- 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.)
Who You Are
You're a kind, passionate and collaborative individual, excited by the prospect of rolling up your sleeves to tackle meaningful problems each and every day. 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 and are willing to learn the legal and regulatory landscape that impacts our products and services.
- 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
Extra Credit
- 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)
Where you’ll work
This role can be based remotely or in our NYC or Durham office. For NY and Durham candidates you’ll have a defined work location that includes work from home and 3 office days set by you and your team. For more information on our approach to hybrid work, please visit the how we work website.
Life at Flatiron
At Flatiron Health, we offer a full range of benefits to support you and your loved ones so you can focus your working hours on improving cancer care and accelerating cancer research, and your non-working hours on everything else life has to offer:
- Work/life autonomy via flexible work hours and flexible paid time off
- Comprehensive compensation package
- 401(k) contribution to help you reach your retirement planning goals
- 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
In addition to our robust benefit offerings, visit our Life at Flatiron page to learn how we support continuous learning and celebrate Diversity in the workplace.