Regulatory and Legal Operations Manager

Job not on LinkedIn

🔥 0 minutes ago

🗽 New York, North Carolina – Remote

🗽 New York – Remote 🌲 North Carolina – Remote

💵 $114.4k - $157.3k / year

⏰ Full Time

🟡 Mid-level

🟠 Senior

⚙️ Operations

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This company has sponsored H1B visas in the past.

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Flatiron Health

WebsiteLinkedInAll Job Openings

1001 - 5000 employees

Founded 2012

🏥 Healthcare

💼 Consulting

⚖️ Legal

💰 $11.9M Series D on 2021-12

Healthcare • Consulting • Legal

Flatiron Health is a company dedicated to reimagining the infrastructure of cancer care. The company provides solutions across the cancer care industry to enhance and learn from each patient's experience. Flatiron Health focuses on designing and operating better clinical trials, accelerating drug development and access, and enabling smarter cancer care through real-world evidence and clinical research. The company prioritizes data confidentiality and compliance, ensuring robust legal and privacy measures.

📋 Description

• 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

🎯 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 • 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)

🏖️ Benefits

• 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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