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8 дней назад

Regulatory and Legal Operations Manager (Healthcare Technology)

Формат работы
remote (только USA)/hybrid
Тип работы
fulltime
Грейд
middle
Английский
b2
Страна
US
Вакансия из списка Hirify.GlobalВакансия из Hirify Global, списка международных tech-компаний
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Описание вакансии

Текст:
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TL;DR
Regulatory and Legal Operations Manager (Healthcare Technology): Managing regulatory programs, compliance processes, certification requirements, and contract lifecycle operations for oncology point-of-care products with an accent on cross-functional execution, legal technology, and healthcare regulations. Focus on maintaining ONC certification compliance, improving Ironclad workflows, implementing AI-enabled legal tools, and coordinating complex regulatory and legal operations projects.

Location: Remote within the US, or hybrid from the New York City or Durham office with 3 office days set by the employee and team.

Company

hirify.global develops technology for cancer care and oncology research.

What you will do

  • Develop and execute the regulatory program roadmap, translating requirements into actionable plans and coordinating completion across Legal, Product, technical teams, and external certification bodies.
  • Manage regulatory compliance processes, training, reporting, incidents, corrective action plans, and certification standing for regulated products and services.
  • Monitor healthcare regulatory developments and participate in relevant regulatory communities to inform business decisions.
  • Manage the Ironclad contract lifecycle management system, workflows, documentation, training, contract routing, archiving, KPI reporting, and process improvements.
  • Identify and implement tools, including AI functionality, to improve Legal team efficiency and develop legal and regulatory knowledge management practices.

Requirements

  • 3–5 years of experience in operations, program management, or project management in a highly regulated environment, ideally in health technology or healthcare.
  • Familiarity with software development and contracting processes and willingness to learn the legal and regulatory landscape affecting products and services.
  • Strong problem-solving and project management skills, with demonstrated success managing projects with multiple dependencies and maintaining stakeholder accountability and relationships.
  • Ability to make autonomous decisions while communicating openly, collaborating, seeking input, and escalating issues appropriately.
  • Ability to prioritize competing workstreams, synthesize and explain complex topics to cross-functional stakeholders, learn quickly, and work effectively with ambiguity and limited information.

Nice to have

  • Knowledge of ONC Health IT certification and CMS regulatory programs such as MIPS.
  • Experience with legal department technology, including Ironclad, contract lifecycle management software, or DocuSign.
  • Experience identifying, implementing, or leveraging AI tools or AI agents such as Credal, Claude Cowork, or Gemini for legal or regulatory processes.

Culture & Benefits

  • Flexible work hours, work/life autonomy, and flexible paid time off.
  • Comprehensive compensation and benefits, including 401(k) contributions and financial health resources.
  • Mental well-being services and parental, fertility, adoption, surrogacy, and family-building benefits.
  • Travel support for safe healthcare services and support for continuous learning.
  • Collaborative work focused on improving cancer care and accelerating cancer research.

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