Strategic Regulatory Affairs Manager, Medical Devices

Katalyst CRO; Austin (TX); On-site; USD 100,000 - 150,000; Full time

Job summary

Dentsply Sirona Essential Dental Solutions is seeking an experienced Regulatory Affairs leader to oversee day-to-day operations of the team and drive regulatory strategy for medical devices globally.

You will manage 510(k) submissions, liaise with FDA and EU bodies, mentor staff, and ensure compliance across US and international markets while supporting product development through lifecycle.

Strong leadership, regulatory writing, and project management skills are essential.

Qualifications

• 5+ years of experience in regulatory affairs, preferably in the medical device industry.
• Experience with leading regulatory submissions and managing regulatory projects.
• In-depth knowledge of FDA 510(k) and international regulations (e.g., EN ISO 13485, EU MDR).

Responsibilities

• Overseeing day-to-day functions of the Dentsply Sirona Essential Dental Solutions team.
• Develops regulatory strategies for existing, new, and modified medical devices and other (regulated) products.
• Manages and submits 510ks for the products and manages communications with FDA including pre-subs.
• Mentors and guides direct reports and cross-functional teams on US and EU regulatory requirements.
• Works with business partners for registrations to ensure global compliance and champions initiatives to improve systems and compliance.
• Develops and implements strategies to obtain and maintain regulatory approvals for medical devices globally.
• Leads regulatory submissions, including 510(k) submissions, and technical files for CE marking.
• Manages communications with FDA and EU notified bodies for pre-submissions, 510(k) submissions, and CE technical files.
• Provides regulatory guidance to cross-functional teams across the product lifecycle.
• Reviews and interprets regulatory requirements to ensure compliance.
• Coordinates regulatory activities with internal teams and external agencies.
• Reviews and approves product labeling and claims for US/EU markets.
• Keeps current with regulatory requirements and updates policies.
• Fosters professional interactions with stakeholders and mentors regulatory staff.
• Performs other duties as assigned or needed.

Skills

Regulatory leadership

FDA submissions

Regulatory strategy

Communication

Cross-functional collaboration

Education

Bachelor's degree

Tools

Microsoft Office

Regulatory software

Job description

Dentsply Sirona Essential Dental Solutions is seeking an experienced Regulatory Affairs leader to oversee day-to-day operations of the team and drive regulatory strategy for medical devices globally.

You will manage 510(k) submissions, liaise with FDA and EU bodies, mentor staff, and ensure compliance across US and international markets while supporting product development through lifecycle.

Strong leadership, regulatory writing, and project management skills are essential.