Overview
This role supports expanding commercial operations and a comprehensive healthcare compliance framework. Responsibilities include structuring commercial relationships, managing healthcare regulatory risk, overseeing commercial and research contracting, and advising cross-functional teams on compliance and privacy.
The position is fully remote with occasional travel required for team meetings and cross-functional projects.
Responsibilities
- Draft, review, and negotiate agreements with health systems, physician practices, imaging providers, payors, channel partners, and vendors, including:
- Master service agreements
- Business associate agreements
- Data-use agreements
- Strategic partnerships
- Draft, review, and negotiate research agreements with external sponsors, including:
- Clinical trial agreements
- Research grant agreements
- Investigator-initiated agreements
- Core lab services
- Data licensing agreements
- Advise commercial, scientific affairs, regulatory, and other relevant functions on compliance strategies, policies, and practices related to applicable healthcare laws, guidance documents/opinions, and industry codes (including FDCA, fraud and abuse laws, Anti-Kickback Statute, False Claims Act, Sunshine Act, HIPAA, FDA guidance documents, and OIG advisory opinions, etc.).
- Assess commercial arrangements involving healthcare professionals, including consulting, advisory, educational, and research relationships.
- Counsel internal teams on privacy matters, including permissible data uses for strategic initiatives and application of privacy laws (including HIPAA, GDPR, CCPA and other state data privacy laws) to:
- Current business processes
- New product development
- Research collaborations
- Commercial relationships
- Develop and oversee implementation of policies for healthcare and privacy law compliance, privacy management, and data governance.
- Collaborate with information security on data security initiatives, risk management, third-party audits/certifications, and vendor assessments.
- Help prepare for potential cybersecurity or privacy incidents.
- Provide ad hoc legal support on other legal department projects as needed (e.g., employment law; litigation).
Requirements
- JD degree from an ABA-accredited law school and active state bar admission.
- 8+ years of relevant legal and compliance experience at a law firm or in-house.
- Healthcare industry experience required (medical device, pharma, or life sciences).
- Combination of major law firm and in-house experience, including substantial healthcare regulatory counseling and commercial contracting.
- Strong knowledge of healthcare compliance, including healthcare fraud and abuse laws, FDA promotional requirements, Advamed principles, HCP/HCO interactions, HIPAA, transparency and privacy requirements.
- Experience developing compliance processes and scalable contracting tools in a growth-stage business.
- Ability to manage competing priorities and work independently within a lean legal team.
- Strong legal analysis, business judgment, communication, stakeholder management, and problem-solving skills.
- Proven ability to translate complex legal requirements into clear, practical recommendations and to build and maintain strong relationships with internal and external stakeholders.
Preferred Qualifications
- In-house experience at a healthcare technology, medical device, diagnostic, digital health, or other regulated healthcare company strongly preferred.
Compensation & Benefits
- Base salary range: $225,000-$265,000 (varies by location and aligned to market benchmarks).
- Candidates located in higher-cost labor markets, including California, Washington, New York, New Jersey, Connecticut, Massachusetts, and Washington, DC represent the middle to high end of the range.
- Candidates located in all other U.S. locations represent the low to middle end of the range.
- Final compensation is determined based on location, experience, skills, and internal equity.
- 15% target annual bonus.
- Total Target Compensation (TTC): Total cash compensation (including base pay, variable pay, commission, bonuses, etc.); stock options, paid benefits, and employee perks are part of total rewards.
Location
Fully remote role with occasional travel required for team meetings and cross-functional projects.