Regulatory Affairs Manager

Job Summary

A company is looking for a Regulatory Affairs Manager.

Key Responsibilities

• Oversee the US and EU based Regulatory Affairs team and execute regulatory strategies for medical and non-medical devices
• Lead regulatory submissions, including US 510(k)s and CE marking, and provide guidance on product lifecycle planning
• Monitor global regulations and assist in the development of technical documentation for regulatory approval

Required Qualifications, Training, and Education

• Bachelor's degree in a relevant field or equivalent experience
• 9 - 10 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 I and II medical devices, and familiarity with Class III devices is a plus
• Knowledge of Medical Devices Regulations and related standards