Regulatory Program Manager

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 Program 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. Key job responsibilities includes:

• Develop, implement, and refine regulatory program processes that support compliance with industry regulations.
  • Work closely with cross-functional teams to ensure that processes are integrated into workflows, especially those involving product development.
  • Continuously evaluate and improve processes to ensure efficiency and effectiveness, incorporating feedback from technical and legal teams.
• Develop and execute against the regulatory program roadmap to ensure regulatory requirements are timely and effectively implemented
  • Develop and track metrics/feedback to evaluate the effectiveness of Flatiron’s regulatory program, adjusting program and processes as needed 
  • Serve as primary liaison between legal and business and technical stakeholders to translate regulatory requirements into actionable plans
  • Partner closely with technical teams to integrate regulatory requirements into product design and workflows. Serves as main point-of-contact for regulatory questions during product scoping and development.
  • Drive accountability with teams to ensure timely completion of regulatory requirements
• Manage regulatory program risk
  • Monitor the overall compliance of Flatiron’s regulated products and services
  • Identify regulatory risks and develop and execute mitigation strategies
  • Routinely report on program status, risks, and issues to leadership and recommend corrective actions.
• Develop and maintain knowledge management best practices to ensure all regulatory compliance documents, including policies and procedures, are easily accessible and up-to-date.
• Develop and implement training programs to educate relevant teams on regulatory requirements, policies, and best practices and ensure that teams understand how regulatory compliance impacts their work.

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 processes and are willing to learn the regulatory landscape that impacts our products and services.  

• You have robust 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, EOM)

Where you’ll work

In this hybrid role, you’ll have a defined work location that includes work from home and 3 office days set by you and your team with the option of being Flex or Office. For more information on our approach to hybrid work as well as our work type options, 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.