Massachusetts Licensed Regulatory Affairs Principal

Job Summary

To support regulatory compliance for high-risk AI products, the full-time remote Massachusetts Licensed Regulatory Affairs Principal will develop and execute regulatory strategies, manage submissions, and provide guidance on product lifecycle planning.

Key responsibilities

• Develop and execute regulatory strategies for FDA Class III devices
• Lead and manage regulatory submissions and interactions with regulatory authorities
• Monitor and interpret evolving global regulations to ensure compliance

Required qualifications

• Bachelor's degree in a life science, engineering, or related field; advanced degree or Regulatory Affairs Certification preferred
• 13 - 17 years of experience in a regulated industry, preferably with FDA and Software as a Medical Device
• Strong knowledge of FDA Quality System Regulations and experience with regulatory filings
• Experience with US FDA Class III devices and interactions with regulatory authorities
• International submission experience for high-risk devices is preferred