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.
- 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.
Austin Vita is acting as an Employment Agency in relation to this vacancy.
Austin Vita is committed to being an equal opportunities employer, and encourages applications from candidates regardless of sex, race, disability, age, sexual orientation, gender reassignment, religion or belief, marital status, or pregnancy and maternity status.
Due to the volume of applications received, we are unable to provide individual feedback to unsuccessful applicants.