Overview
The organization is seeking an Associate General Counsel, Healthcare Products to serve as a strategic legal advisor to business areas and functional teams in North America. This role supports the development, manufacture, regulatory compliance, lifecycle management, and commercialization of medical technology products.
You will partner closely with stakeholders across research and development, product management, engineering, quality, regulatory, supply chain, manufacturing, procurement, clinical, medical, and other operational functions to provide practical legal guidance throughout the product lifecycle.
The Associate General Counsel will also support the Legal Department’s continued adoption of technology-enabled legal service delivery, including artificial intelligence, contract lifecycle management, and other legal operations tools to enhance efficiency, consistency, and risk management.
Responsibilities
- Provide legal advice to product area leadership and functional stakeholders in North America on legal, regulatory, and contractual issues affecting the development, manufacture, distribution, and support of medical technology and healthcare technology products.
- Draft, review, and negotiate a broad range of agreements for North America, including development agreements, clinical and research agreements, technology and software agreements, supply and manufacturing agreements, quality agreements, distribution agreements, and strategic collaboration agreements.
- Support research and development, engineering, product management, and innovation teams for new product development, product enhancements, software-enabled technologies, artificial intelligence solutions, and other strategic initiatives.
- Support sourcing and procurement teams regarding transactions and transformative initiatives.
- Advise stakeholders on legal issues arising under the Food, Drug and Cosmetic Act, healthcare fraud and abuse laws, data privacy and cybersecurity requirements, and related regulations impacting the medical technology industry.
- Partner with sales leadership and teams to structure and negotiate customer transactions, commercial programs, and arrangements in compliance with applicable healthcare fraud and abuse, transparency, and related healthcare regulatory requirements.
- Advise marketing and commercial operations on promotional materials and strategies in compliance with applicable medical device promotional rules.
- Support strategic transactions, acquisitions, integrations, product launches, technology partnerships, and other growth initiatives.
- Collaborate across legal, intellectual property, ethics & compliance, regulatory, quality, medical and clinical affairs, data privacy, information technology, and operations to identify and manage legal and business risks.
- Help develop legal department standards, templates, playbooks, workflows, and self-service tools to improve consistency, efficiency, and risk management.
- Contribute to the adoption and advancement of legal technology solutions, including AI-enabled tools, Enterprise Legal Management (ELM) systems, Contract Lifecycle Management (CLM) systems, and other technology-enabled legal operations initiatives.
- Maintain high standards for ethical behavior and compliance with applicable laws, regulations, and company policies.
- Use sound judgment to escalate legal issues and develop practical, business-oriented solutions.
Minimum Requirements
- Experience: Minimum 7 years of relevant legal experience, including significant law firm and/or in-house experience.
- Education and License: Juris Doctor (JD) from an accredited program and active admission to at least one US state bar.
- Commercial Contracting: Deep experience and comfort drafting, negotiating, and advising internal stakeholders regarding complex and routine commercial agreements with external stakeholders.
- Legal Technology: Experience with ELM and AI tools to enhance and streamline in-house legal services.
- Regulated Business: Familiarity with providing legal advice in a highly regulated business (e.g., FDCA, AKS, FCA and HIPAA).
Required Knowledge, Skills, and Abilities
- Agility: Proven success and comfort working in a fast-paced environment where practical legal advice must be provided and operationalized quickly while balancing competing priorities.
- Effective Communication: Exceptional interpersonal and verbal/written communication skills to build trust and strong relationships with colleagues and clients.
- Motivation: Highly self-motivated to advance routine work and complex projects independently across multiple stakeholders.
- Digital Fluency: Experienced and comfortable leveraging modern technology (e.g., AI and ELM/CLM) to enhance legal service delivery.
Compensation & Benefits
- Salary range: $210,000 - $255,000/annually + 25% STIP
- Benefits include:
- Health, dental, and vision insurance benefits
- 401(k) plan with company match
- Paid Time Off
- Wellness initiative & health assistance resources
- Life insurance
- Short- and long-term disability benefits
- Health and dependent care flexible spending accounts
- Commuter benefits
- Parental and caregiver leave
- Tuition reimbursement
Location
Equal Opportunity
The employer is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, pregnancy, genetic information, national origin, disability, protected veteran status, or any other protected characteristic under law. Reasonable accommodations are available upon request for candidates participating in the selection process.