Regulatory and Legal Operations Manager

🕒 Outubro 28

🗽 New York, North Carolina – Remoto

🗽 New York – Remote 🌲 North Carolina – Remote

💵 $114.400 - $157.300 / ano

⏰ Tempo Integral

🟡 Pleno

🟠 Sênior

⚙️ Operações

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Esta empresa já patrocinou vistos H1B no passado.

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Flatiron Health

SiteLinkedInTodas as Vagas

1001 - 5000 funcionários

Fundada em 2012

🏥 Saúde

💼 Consultoria

⚖️ Jurídico

💰 $11.900.000 Series D em 2021-12

Healthcare • Consulting • Legal

A Flatiron Health é uma empresa dedicada a reinventar a infraestrutura do cuidado com o câncer. A empresa oferece soluções em toda a indústria de cuidado oncológico para melhorar e aprender com a experiência de cada paciente. A Flatiron Health se concentra no design e operação de melhores ensaios clínicos, na aceleração do desenvolvimento e acesso a medicamentos e na habilitação de um cuidado oncológico mais inteligente através de evidências do mundo real e pesquisa clínica. A empresa prioriza a confidencialidade e conformidade dos dados, garantindo medidas robustas de privacidade e legais.

Descrição

• Develop and execute the regulatory program roadmap • Liaise between Legal, business, and technical stakeholders to translate regulatory requirements into actionable plans • Drive accountability for timely completion of regulatory requirements • Compile and submit regulatory reports across Product, Legal, and external certification bodies • Manage and improve regulatory program processes supporting compliance • Manage training programs on regulatory requirements, policies, and best practices • Monitor compliance of regulated products and services • Support regulatory incidents and corrective action plans • Maintain good standing with federal regulatory certification programs, including ONC certification • Participate in regulatory communities and analyze policy changes • Drive contract lifecycle management for commercial agreements • Maintain and configure Ironclad CLM tools and workflows • Maintain contracting documentation and train sales representatives and account managers • Route contracts for signature and archive executed agreements • Establish CLM KPI reporting and data-driven process improvements • Lead Legal team efficiency projects and implement tools, including AI functionality • Assist with legal and regulatory knowledge management systems and practices • Report to the Director of Legal and Regulatory Operations

🎯 Requisitos

• 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 • Robust problem-solving and project management skills • Demonstrated success executing projects with multiple dependencies and maintaining stakeholder accountability and relationships • Ability to make autonomous decisions and execute while maintaining open communication • Ability to identify priorities and manage competing workstreams • Excellent communication skills, including synthesizing, simplifying, and explaining complex topics to cross-functional stakeholders • Ability to learn quickly in a fast-paced environment • Comfort with ambiguity and developing hypotheses with limited information • Knowledge of ONC Health IT certification and certain CMS regulatory programs such as MIPS (extra credit) • Experience with legal department technology solutions such as Ironclad/CLM and DocuSign (extra credit) • Experience identifying, implementing, or leveraging AI tools or agents for legal or regulatory processes (extra credit)

🏖️ Benefícios

• Work/life autonomy via flexible work hours and flexible paid time off • Comprehensive compensation package • 401(k) contribution • 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 • Continuous learning support • Diversity and inclusion initiatives

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