Regulatory Affairs Manager

Dentsply Sirona seeks a full-time Regulatory Affairs Manager to lead the regulatory strategy and day-to-day operations for the Implants and Prosthetics division in Schiller Park, Cook County. In this role, you'll guide medical device products through the FDA regulatory pathway and ensure compliance across all product portfolios.

About This Position

This is a leadership opportunity within Dentsply Sirona's Implants and Prosthetics business unit. You'll be responsible for crafting and executing regulatory strategies that bring new, modified, and existing medical devices to market efficiently and in full compliance with FDA requirements. Your work directly impacts product development timelines and market success for one of the world's leading dental device manufacturers.

Your Responsibilities

• Oversee the day-to-day regulatory functions and team operations for the Implants and Prosthetics division
• Develop comprehensive regulatory strategies for new, modified, and existing medical devices and regulated products
• Prepare, manage, and submit 510(k) applications to the FDA
• Lead pre-submission meetings and coordinate ongoing communications with FDA reviewers
• Ensure all regulatory documentation is accurate, complete, and compliant with applicable regulations
• Mentor and guide cross-functional teams on regulatory requirements and best practices

What We're Looking For

• Proven experience managing regulatory submissions, including 510(k) applications for medical devices
• Deep knowledge of FDA regulations, guidance documents, and pre-submission processes
• Track record of leading regulatory strategy for dental or medical device products
• Strong project management and organizational skills with ability to oversee multiple submissions
• Excellent written and verbal communication for FDA interactions and cross-team collaboration
• Demonstrated ability to work independently and lead a regulatory team effectively

Working at Dentsply Sirona

As part of Dentsply Sirona's leadership team, you'll contribute to advancing dental innovation and improving patient outcomes globally. We value regulatory expertise and provide the resources, support, and professional environment needed to excel in this critical role.

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