We have partnered with our client in their search for a Regulatory Counsel, Medical Devices
Responsibilities
- Provide legal advice on regulatory and quality matters across the medical device product life cycle, including compliance, risk management, and process development.
- Counsel cross-functional teams on regulatory strategy, including support for De Novo and 510(k) pathways, audits, inspections, and evolving global regulatory requirements.
- Partner with business, product, quality, and operational stakeholders to mitigate risk, support innovation, and enable compliant growth in data-driven healthcare solutions.
Skills Required
- Strong experience advising medical device companies on FDA regulatory matters, including direct work with De Novo and 510(k) submissions and 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
Degree
J.D. from an accredited law school; active U.S. bar membership required.
Work Experience
8+ years of legal experience, with significant experience in the medical device industry advising on FDA regulatory strategy, compliance, and quality-related matters.
About Korn Ferry
Korn Ferry unleashes potential in people, teams, and organizations. We work with our clients to design optimal organization structures, roles, and responsibilities. We help them hire the right people and advise them on how to reward and motivate their workforce while developing professionals as they navigate and advance their careers. To learn more, please visit Korn Ferry at www.Kornferry.com
