Regulatory Affairs Specialist

Dentsply Sirona is seeking an experienced Regulatory Affairs Specialist to support regulatory market access activities for US, Canada, EU, and other countries. The ideal candidate will have 1-5 years of experience in regulatory affairs, preferably in the medical device industry.

Requirements

• Prepares and submits international regulatory submissions to obtain and maintain regulatory approvals for medical devices
• Maintains regulatory files and databases to ensure compliance with regulatory requirements
• Reviews and interprets regulatory requirements and guidance documents to ensure compliance
• Coordinates regulatory activities with internal teams and external regulatory agencies
• Supports regulatory audits and inspections as SME for questions related to market access