Regulatory Affairs Manager

🔥 0 minutes ago

🌲 North Carolina – Remote

🌲 North Carolina – Remote

⏰ Full Time

🟡 Mid-level

🟠 Senior

🚔 Compliance

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Dentsply Sirona

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 1899

🧬 Biotechnology

Healthcare • Biotechnology • Medical Devices

Dentsply Sirona is a leading global provider of dental solutions dedicated to transforming dentistry worldwide. The company works with dental professionals in over 50 countries to deliver innovative and revolutionary products that enhance oral health. With a focus on research, development, and manufacturing, Dentsply Sirona aims to impact the dental industry positively both today and in the future, offering a range of opportunities in various business areas including sales, supply chain, and corporate functions.

📋 Description

• 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.

🎯 Requirements

• 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.

🏖️ Benefits

• Competitive salary • Flexible working hours • Professional development budget • Home office setup allowance • Global team events