Overview
This role involves providing legal counsel on regulatory and quality matters throughout the medical device product life cycle. The position supports compliance, risk management, and process development related to medical devices.
Responsibilities
Provide legal advice on regulatory and quality issues across the medical device product life cycle.
Counsel cross-functional teams on regulatory strategy, including support for De Novo and 510(k) pathways.
Assist with audits, inspections, and adapting to evolving global regulatory requirements.
Collaborate with business, product, quality, and operational stakeholders to mitigate risk, support innovation, and enable compliant growth in data-driven healthcare solutions.
Requirements
Strong experience advising medical device companies on FDA regulatory matters.
Direct experience with De Novo and 510(k) submissions and regulatory strategy.
Ability to guide legal and business teams on regulatory compliance, quality systems, inspections, audits, and product life cycle risk management.
Practical, business-oriented approach with the ability to work cross-functionally in a remote, distributed environment.
Education & Work Experience
J.D. from an accredited law school.
Active U.S. bar membership required.
Minimum of 8 years of legal experience.
Significant experience in the medical device industry advising on FDA regulatory strategy, compliance, and quality-related matters.
Location
This position supports remote work in a distributed environment.