Regulatory Affairs Specialist

Overview

Regulatory Affairs Specialist role at Dozee focused on regulatory strategy and submissions for medical devices and SaMD products.

What you'll do

• Drive global regulatory strategy for medical devices and SaMD products.
• Manage regulatory submissions.
• Ensure compliance with FDA and EU MDR.
• Ensure compliance with international standards.
• Mentor a growing regulatory team.

What you'll need

• Experience with regulatory affairs for medical devices and/or SaMD.
• Knowledge of FDA compliance requirements.
• Knowledge of EU MDR compliance requirements.
• Ability to manage regulatory submissions.
• Mentoring/leadership capability for a regulatory team.

Details

• Location: Bangalore.