Regulatory Affairs Manager

Job Summary

Overseeing the daily operations of the Implants and Prosthetics team, the full-time remote Regulatory Affairs Manager will develop regulatory strategies for medical devices, manage 510(k) submissions, and mentor cross-functional teams on compliance with US and EU regulations.

Key Responsibilities

• Develops and implements regulatory strategies to obtain and maintain regulatory approvals for medical devices and other regulated products globally
• Leads and manages regulatory submissions, including 510(k) submissions and technical files for CE marking
• Provides regulatory guidance and support to cross-functional teams throughout the product lifecycle

Required Qualifications

• Bachelor's degree in a relevant field, such as life sciences, regulatory affairs, or a related discipline
• 5+ years of experience in regulatory affairs, preferably in the medical device industry
• In-depth knowledge of FDA 510(k) and international regulations (e.g., EN ISO 13485, EU MDR)
• Regulatory Certification (such as RAC) or a Master's degree in a scientific discipline is a plus
• Experience with software as a medical device, AI, and/or medical devices containing software is a plus