Regulatory and Legal Operations 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 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

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