Senior Regulatory Affairs Specialist

Dentsply Sirona is seeking a Senior Regulatory Affairs Specialist to contribute to cross-functional teams in support of regulatory market access activities for US, Canada, EU, and other countries. The successful candidate will assist in developing and executing regulatory strategies, preparing and submitting international regulatory submissions, and providing regulatory guidance to cross-functional teams.

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 documentation, including 510(k) submissions and CE marking
• In-depth 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
• Ability to critically review detailed scientific information and assess whether technical arguments are presented clearly, and conclusions are adequately supported
• Willingness to learn and adapt to new processes and technologies
• Regulatory registration experience within med device organizations
• Prior technical writing experience and proven track record with FDA and EU regulatory submissions preferred

Benefits

• Generous Paid Time Off
• 401k Matching
• Retirement Plan
• Diversity and Inclusion
• Professional Development