Quality & Regulatory Manager

A company is looking for a Quality & Regulatory Manager to oversee its Quality Management System and ensure regulatory compliance.

Key Responsibilities

Lead and manage regulatory submissions, including 510(k) filings and ongoing maintenance

Maintain and improve the Quality Management System (ISO 13485, 21 CFR Part 820)

Drive CAPA investigations and support internal / external audits

Required Qualifications

Bachelor's degree required; Master's degree preferred in Regulatory Affairs, Clinical Research Management, or a related field

5-7 years of experience in regulatory / quality roles in medical devices, SaMD, or digital health

Hands-on experience with FDA 510(k) submissions

Solid working knowledge of QMS standards (ISO 13485, 21 CFR Part 11 / 820, ISO 14971)

Experience in a small company as the sole regulatory / quality owner