Regulatory Affairs Manager

Job Summary

A company is looking for a Regulatory Affairs Manager.

Key Responsibilities:

• Develops and implements regulatory strategies for medical devices and regulated products globally
• Leads regulatory submissions, including 510(k) and technical files for CE marking
• Provides regulatory guidance to cross-functional teams and manages communications with FDA and EU notified bodies

Required Qualifications:

• Bachelor's degree in 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
• Regulatory Certification (such as RAC) or a Master's degree in a scientific discipline is a plus
• Experience with software as a medical device is a plus