Regulatory and Legal Operations Manager

Overview

This role involves managing regulatory and legal operations for point-of-care products to ensure regulatory and certification requirements are met and maintained. You will work at the intersection of technology, law, and healthcare, reporting to the Director of Legal and Regulatory Operations, and partnering with Legal, technical teams, and other business stakeholders.

Responsibilities

• Develop and execute against the regulatory program roadmap to ensure regulatory requirements are timely and effectively implemented.
• Serve as a primary liaison between Legal and business/technical stakeholders to translate regulatory requirements into actionable plans.
• Drive accountability across 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 for efficiency and effectiveness, incorporating feedback from technical and Legal teams.
• Manage training programs to educate relevant teams on regulatory requirements, policies, and best practices; ensure teams understand how regulatory compliance impacts their work.
• Ensure adherence to all regulatory obligations.
• Monitor compliance of regulated products and services.
• Support 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 and industries; gather regulatory policy intelligence and analyze changes in the regulatory environment to inform decision-making.

Contract Lifecycle Management (CLM)

• Drive contract lifecycle management (CLM) to ensure timely execution of commercial agreements.
• Support ongoing maintenance of the 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 executed agreements are correctly archived.
• Establish reporting to assess CLM KPIs and drive data-driven process improvement.

Process Improvement & Legal Tech Enablement

• Identify opportunities and lead projects to enable greater efficiency across the Legal team.
• Identify and implement tools (including AI functionality) to streamline practices; 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., organizing the Legal team drive and document management processes).

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; willingness to learn the legal and regulatory landscape impacting products and services.
• Strong problem-solving and project management skills, with demonstrated success executing projects with multiple dependencies and maintaining accountability and stakeholder relationships.
• Ability to work autonomously with open communication; recognize and escalate issues appropriately to avoid working in isolation.
• Ability to identify priorities and effectively manage competing workstreams.
• Excellent communication skills, including the ability to synthesize, simplify, and explain complex topics to cross-functional stakeholders.
• Demonstrated ability to learn quickly in a fast-paced environment.
• Comfort with ambiguity; able to develop hypotheses with limited information.

Preferred Qualifications (Extra Credit)

• Knowledge of healthcare regulatory programs, including the 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.

Compensation & Benefits

• Salary range: $114,400 - $157,300.
• An annual bonus and equity may be provided as part of the compensation package.
• Medical, financial, and/or other benefits are included depending on the position offered.
• 401(k) contribution.
• Flexible work hours and flexible paid time off.
• 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.

Location & Work Arrangement

• Remote or in NYC or Durham office.
• For NY and Durham candidates: defined work location that includes work from home and 3 office days set by you and your team.