Regulatory Affairs Manager

This is a fully remote position, open to applicants in Florida, +4 more states.

📋 Description

• Supervising the daily operations of the Dentsply Sirona Essential Dental Solutions team

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

• Overseeing the management and submission of 510(k) applications for the products

• Handling communications with the FDA, including pre-submission inquiries

• Coaching and offering support to direct reports and cross-functional product development teams regarding US and EU regulatory requirements

⛳️ Requirements

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

• A minimum of 5 years of experience in regulatory affairs, ideally 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)

• Leadership experience in medical device organizations

• Expertise in Microsoft Office Suite

• Familiarity with regulatory software

🏝️ Benefits

• Opportunities for professional development

• Flexible working hours