Overview
Skills
Job Details
Position: Regulatory Strategy Advisor (FDA Approval Process)
Location: Remote
Duration: 6-12 months (fractional engagement)
<>Overview</>
We are seeking an experienced Regulatory Strategy Advisor to guide a medical technology organization through the FDA approval process for a neuro-electric medical device. This role is critical in ensuring compliance with FDA guidelines, minimizing organizational risk, and providing strategic oversight throughout the regulatory journey.
<>Key Responsibilities</>
- Serve as a strategic advisor on FDA approval pathways (e.g., 510(k), PMA), compliance requirements, and regulatory best practices.
- Provide operational guidance on navigating FDA processes, including testing protocols and documentation standards.
- Advise on risk mitigation strategies to limit exposure to affiliated entities.
- Collaborate with internal legal counsel and external FDA consulting partners to ensure alignment and compliance.
- Assess and recommend staffing needs related to quality control, regulatory affairs, and operational support.
- Offer insights on governance structure and compliance frameworks for the duration of the approval process.
- Act as a liaison and buffer between the organization and third-party FDA consultants, ensuring vested interests are protected.
<>Qualifications</>
- Proven experience in FDA regulatory strategy for medical devices, including familiarity with 510(k) submissions and classification requirements.
- Deep knowledge of compliance guidelines, quality systems, and governance standards in the medical device industry.
- Understanding of legal implications and risk management related to FDA approval processes.
- Strong ability to operate in an advisory capacity, providing strategic and operational guidance without direct execution responsibilities.
- Excellent communication skills and ability to work collaboratively with legal, compliance, and operational teams.
<>Engagement Details</>
- Fractional role with flexible hours; remote work supported.
- Estimated engagement: 6-12 months, depending on regulatory timelines.
- Competitive hourly rate commensurate with expertise.
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 ;/span>