Regulatory Affairs Director

A company is looking for a Regulatory Affairs Director.

Key Responsibilities

Develop and implement global regulatory strategies aligned with business objectives

Manage and develop a team of regulatory professionals, ensuring compliance with regulations

Lead regulatory submissions and maintain technical documentation for product approvals

Required Qualifications

Bachelor's degree in a relevant field or equivalent experience

15+ 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 related standards