Regulatory Affairs Manager - EU

Job Summary

A company is looking for a Regulatory Affairs Manager - EU.

Key Responsibilities

• Oversee the US and EU based Regulatory Affairs team and execute regulatory strategies for medical and non-medical devices
• Lead regulatory submissions and manage interactions with regulatory bodies for product approvals
• Monitor global regulations and ensure compliance while providing guidance to cross-functional teams on regulatory requirements

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, with additional experience in Class III devices preferred
• Knowledge of Medical Devices Regulations and standards such as ISO 13485 and ISO 14971