Digital Health Regulatory Affairs Manager

Job Summary

To support the development of innovative cardiovascular solutions, the fully remote Digital Health Regulatory Affairs Manager will manage FDA clearance strategies for Class II & III medical devices, serve as a liaison for global regulatory teams, and provide regulatory guidance on cybersecurity and software-related issues.

Key responsibilities:

• Develop strategies for FDA clearance or approval of cardiovascular medical devices and improvements to existing products
• Advise on global regulatory requirements and prepare FDA submissions while interacting with regulatory agencies
• Support cross-functional teams in new product development projects, focusing on cybersecurity and software compliance

Required qualifications:

• Minimum of 6 years' Regulatory Affairs experience with a Bachelor's degree or 5 years' experience with an advanced degree
• Degree in Computer Science/Engineering or Science is required
• Experience in the medical device industry with successful FDA submissions or review experience in cybersecurity
• Proven ability to communicate with FDA reviewers and lead regulatory discussions
• Strong understanding of FDA requirements and guidance documents, including ISO and IEC standards