About this role

Overseeing the day-to-day functions of the Dentsply Sirona Implants and Prosthetics team.
Developing regulatory strategies for existing, new, and modified medical devices and other (regulated) products.
Managing and submitting 510ks for the products and managing communications with FDA including pre-subs.
Mentoring and providing guidance to direct reports and cross-functional product development teams on US and EU regulatory requirements.
Working closely with business partners for registrations in their respective countries to ensure compliance globally.

Bachelor's degree in a relevant field, such as life sciences, regulatory affairs, or a related discipline.
5(+) years of experience in regulatory affairs, preferably in the medical device industry.
Experience with leading regulatory submissions and managing regulatory projects.
In-depth knowledge of FDA 510(k) and international regulations (e.g., EN ISO 13485, EU MDR).
Experience with software as a medical device, AI and/or medical devices containing software is a plus.
Proficiency with Microsoft Office Suite.
Proficiency with Regulatory software.

Regulatory Affairs Manager

Key skills