Regulatory Affairs Manager

Dentsply Sirona is seeking a Regulatory Affairs Manager to oversee the day-to-day functions of the Dentsply Sirona Essential Dental Solutions team and develop regulatory strategies for existing, new, and modified medical devices and other regulated products.

Requirements

• Develops and implements regulatory strategies to obtain and maintain regulatory approvals for medical devices and other regulated products globally.
• Leads and manages regulatory submissions, including 510(k) submissions, and technical files for CE marking.
• Manages communications with FDA and EU notified bodies on behalf of the company for FDA pre submissions, FDA 510(k) submissions and EU technical files submissions.
• Provides regulatory guidance and support to cross-functional teams throughout the product lifecycle.
• Coordinates regulatory activities with internal teams and external regulatory agencies.
• Reviews and approves product labelling and claims for the US and EU markets.
• Stays current with regulatory requirements and updates affected policies and procedures.
• Fosters professional interactions with internal and external stakeholders through various communication channels, enhancing business relationships.
• Manages day to day activities for less senior Regulatory Affairs professionals, including but not limited to mentoring, coaching, performance reviews, developmental plans, succession planning.