Regulatory Affairs Manager

A company is looking for a Regulatory Affairs Manager.

Key Responsibilities

Maintain the Quality Management System (QMS) and ensure compliance with regulatory standards

Collaborate with cross-functional teams to design workflows that enhance quality without hindering product velocity

Lead documentation efforts and support product teams through process changes and onboarding

Required Qualifications

3+ years of experience in quality, compliance, regulatory, or technical program management

Experience with QMS systems and FDA documentation workflows

Proven ability to implement structured processes in fast-paced environments

Basic technical fluency in machine learning, product development, and system design

Experience with ISO 13485 or FDA SaMD regulations is a plus