Global Regulatory Affairs Leader - Hybrid Medical Devices

Dentsply Sirona Inc.; Sarasota (FL); Hybride; USD 154 000 - 165 000; Plein temps

Résumé du poste

Dentsply Sirona is seeking a Regulatory Affairs Manager to oversee the RA team for orthodontics and other regulated devices. The role develops regulatory strategies, manages 510(k) submissions, and coordinates with FDA, Health Canada, and EU bodies.

You will mentor staff, ensure compliance across Canada, US, and EU, and drive continuous improvement in regulatory processes in a hybrid setup.

Qualifications

• 5+ years of regulatory affairs experience, preferably in medical devices.
• Experience leading regulatory submissions and managing projects.
• Deep knowledge of FDA 510(k) and international regulations (EU MDR, EN ISO 13485, MDSAP).
• Experience with software as a medical device and AI-enabled devices.
• Prior people management experience.

Responsabilités

• Develop and implement regulatory strategies to obtain and maintain approvals for medical devices globally.
• Lead regulatory submissions including 510(k) and CE labeling; manage Health Canada and EU interactions.
• Mentor and guide junior staff; coordinate with cross-functional teams across regions.
• Review regulatory requirements and ensure full compliance across product lifecycles.

Connaissances

Leadership

Regulatory submissions

FDA 510(k)

Regulatory knowledge (ISO 13485, MDSAP

Software as medical device

Formation

Bachelor's degree in life sciences or regulatory field

Regulatory Certification (RAC) or Master’s degree

Outils

Microsoft Office Suite

Regulatory software

Description du poste

Dentsply Sirona is seeking a Regulatory Affairs Manager to oversee the RA team for orthodontics and other regulated devices. The role develops regulatory strategies, manages 510(k) submissions, and coordinates with FDA, Health Canada, and EU bodies.

You will mentor staff, ensure compliance across Canada, US, and EU, and drive continuous improvement in regulatory processes in a hybrid setup.