Regulatory Affairs Specialist
Dentsply SironaHighlight
Summary
About the Role
About You
- Bachelor's degree in a relevant field, such as life sciences, regulatory affairs, or a related discipline.
- 1-5 years of experience in regulatory affairs, preferably in the medical device industry.
- Experience with regulatory submissions and documentation, including 510(k) submissions and CE marking.
- Knowledge of FDA regulations and international standards (e.g., ISO 13485, MDSAP, EU MDR).
- Proficiency with Microsoft Office Suite and Regulatory software.
- Strong attention to detail and organizational skills.
- Excellent communication (both written and verbal) and interpersonal skills.
- Ability to work effectively in a team environment.
- Knowledge of regulatory affairs principles and practices.
- Prior technical writing experience and proven track record with FDA and EU regulatory submissions.
Benefits
- Competitive salary between $90k and $110k.
- Hybrid working arrangement available.
- Professional development opportunities.
A Global Total Solutions Provider Dentsply Sirona is the world’s largest manufacturer of professional dental products and technologies, empowering dental professionals to provide better, safer and faster dental care. Our products and solutions include leading positions and platforms across consumables, equipment, technology, and specialty products. Dentsply Sirona is one global team that brings out the best in our people, lives and breathes high performance and personal accountability, acts with uncompromising integrity, improves the practice of dentistry with an unrelenting commitment to our customers and demonstrates a passion for innovation that shapes the dental industry. As The Dental Solutions Company™ Dentsply Sirona’s comprehensive solutions offering includes leading product brands across consumables, equipment, technology and specialty products. With the broadest clinical education platform and an unparalleled commitment to R&D in dentistry, our mission and vision guide us to continuously aim higher, support our customers and advance patient care around the world. Dentsply Sirona’s Global Headquarters is located in Charlotte, North Carolina. Our shares are listed in the United States on NASDAQ under the symbol XRAY. We care about your privacy - you can view our Privacy Policy here: http://www.dentsplysirona.com/privacy.