Massachusetts Licensed Regulatory Affairs Specialist

Job Summary

To support product commercialization in a remote capacity, the full-time Massachusetts Licensed Regulatory Affairs Specialist will manage regulatory activities for digital products, providing strategic input on compliance and documentation for medical device submissions.

Key responsibilities

• Represent Regulatory Affairs on cross-functional teams and provide guidance on product lifecycle planning and regulatory requirements
• Assess documentation for medical device submissions and communicate regulatory guidance effectively
• Create and maintain technical documentation required for regulatory approval and compliance

Required qualifications

• Bachelor's degree in a relevant field or equivalent experience
• 8 - 12 years of experience in a regulated industry, preferably with FDA and Software as a Medical Device
• Strong knowledge of FDA Quality System Regulations, including 21 CFR 11 and 21 CFR 820
• Experience drafting and submitting regulatory filings, including 510(k) submissions
• Familiarity with pre- and post-market clinical studies and relevant medical device regulations