Regulatory Affairs Manager

This is a fully remote position, open to applicants in North Carolina.

📋 Description

• Supervising the daily operations of the Dentsply Sirona Implants and Prosthetics team.

• Formulating regulatory strategies for existing, new, and modified medical devices as well as other regulated products.

• Overseeing the management and submission of 510(k) applications for products and handling communications with the FDA, including pre-submissions.

• Providing mentorship and guidance to direct reports and cross-functional product development teams regarding US and EU regulatory requirements.

• Collaborating closely with business partners on registrations in their respective countries to ensure global compliance.

⛳️ Requirements

• A Bachelor's degree in a relevant field, such as life sciences, regulatory affairs, or a related discipline.

• At least 5 years of experience in regulatory affairs, preferably within the medical device sector.

• Proven experience in leading regulatory submissions and managing regulatory projects.

• Comprehensive 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 that incorporate software is advantageous.

• Proficient in Microsoft Office Suite.

• Proficient in regulatory software.

🏝️ Benefits

• Competitive salary

• Flexible working hours

• Professional development budget

• Home office setup allowance

• Global team events