Regulatory Affairs Lead

Overview

Join a dynamic company at the forefront of AI-driven healthcare innovation. We are seeking a Regulatory Strategy Manager to play a pivotal role in designing and executing regulatory strategies for AI algorithm development and commercialization in the healthcare sector. Make a difference by helping doctors catch deadly diseases earlier through the adoption of artificial intelligence.

About the Role: You will be responsible for developing sustainable processes and ensuring timely regulatory submissions, with a focus on securing FDA clearance for a steady pipeline of software as a medical device (SaMD) applications via the 510(k) process. This unique opportunity allows you to engage with a wide variety of AI-based SaMD developed by leading academic researchers.

Responsibilities:

• Define and execute regulatory strategies for securing FDA clearance of SaMD applications.
• Ensure compliance with current regulations and guidance.
• Lead the preparation and compilation of regulatory submission documents.
• Coordinate cross-functional teams for input collection and organization.
• Develop innovative regulatory solutions aligned with company goals.
• Provide regulatory expertise to project teams for strategy alignment.
• Establish and manage a Quality Management System (QMS) for medical device development.
• Represent the company in FDA communications and meetings.
• Design, track, and manage metrics for regulatory submission processes.

Skills and Qualifications:

• 4+ years of professional experience in medical device regulatory industry.
• Bachelor's or advanced degree in a relevant field.
• Strong preference for experience with software as a medical device (SaMD) 510(k) submissions involving artificial intelligence.
• Demonstrated success in securing FDA clearance for medical devices.
• Proven track record of executing projects in a corporate environment.
• Excellent organization skills and attention to detail.