Regulatory Associate

Founded in 1947, Pulpdent Corporation is an industry-leading dental research and manufacturing company. Pulpdent’s corporate headquarters, research laboratory, and manufacturing facilities are located in Watertown, Massachusetts, in the Boston metro area. Its products are distributed globally. Pulpdent is third-generation family-owned business that is widely respected for its innovative products and authentic company culture, which promotes work-life balance, employee retention, and product excellence.

The enduring hallmarks of the Pulpdent brand are imagination, dedication, and empowerment, with each of these inspiring the daily work of Pulpdent’s 100-plus employees. To learn more about Pulpdent, including its breakthrough advances in bioactive dental materials and commitment to ethical business practices, visit

Pulpdent’s Regulatory Department is responsible for implementing and maintaining our quality assurance system for the manufacturing of medical devices. The Regulatory Associate assists and supports the Quality Assurance and Regulatory Affairs Director to ensure day-to-day functions run smoothly by maintaining quality systems documentation, owning the process of foreign registrations, acting as the primary point of contact for complaint handling, maintaining staff training records, and more.

• Prepare technical documentation for new or renewed foreign registrations
• Organize and maintain documentation required for foreign regulatory submissions
• Maintain and update training records, procedures, work instructions, and controlled document revisions
• Update and maintain regulatory and quality-related documentation and records.
• Participate in annual audit by notified body, providing back-room support and coordination
• Compile and analyze regulatory information, sales data by country, complaint data, and product usage to support internal reporting, audits, and regulatory activities
• Assist with quality management system maintenance and effectiveness implementation and improvement, serving as a system administrator
• Participate in internal audits
• Maintain and update supplier documentation

• Bachelor’s degree in related field
• 2-4 years minimum office experience
• Proficiency in Microsoft Office
• Science or healthcare background
• Organizational and administrative skills
• Detail oriented

• Familiarity with medical device regulatory landscape
• Experience with medical device foreign registration processes greatly preferred
• Experience with medical devices and manufacturing
• Spanish language abilities

• Ability to sit for long periods of time
• Ability to work on a computer for long periods of time
• Ability to work in a lab

Other duties, responsibilities and activities may change or be assigned at any time with or without notice

PULPDENT® is an equal opportunity employer. We employ a diverse workforce and encourage people of all backgrounds to apply for employment.