Regulatory Affairs Manager

Job Overview

We are searching for the best talent to join our DePuy Synthes Orthopaedics team as a Regulatory Affairs Manager. This position may be based in Synthes, Oberdorf; Zuchwil or the United States: Raynham, MA; West Chester, PA; Palm Beach Gardens, FL. The RA manager leads a team to provide independent regulatory guidance to product development teams in strategic planning, pre‑marketing, and related submissions to support optimal timelines for new or modified product launches. Under minimal supervision, the individual leads the submission of licenses and authorizations for the maintenance of existing products, international registrations, and dossiers. The RA manager serves as the company’s regulatory expert and is responsible for communications with FDA and international regulatory agencies.

Responsibilities

• Provides independent regulatory guidance to product development teams in strategic planning, pre‑marketing, and related submissions to ...