Overview

The Regulatory Affairs Manager II leads the company’s post‑market regulatory program to ensure global compliance for commercialized IL-labeled medical devices and manages a team of regulatory professionals in this endeavor. This leadership role owns all elements related to post-market regulatory compliance to meet worldwide regulatory requirements, including vigilance reporting, recall (product correction and removal) management, on-market product change assessment, and the post-market surveillance (PMS) program. The manager also develops people, builds processes, and represents Regulatory Affairs during management reviews, external and internal inspections and audits.

Responsibilities

Key Accountabilities - Essential Functions: