Pulpdent · 1 week ago
Regulatory Associate
Watertown, MA
Full-time
Onsite
Entry Level
$28/hr - $50/hr
2+ years expPulpdent Corporation is an industry-leading dental research and manufacturing company located in Watertown, Massachusetts. The Regulatory Associate will assist in maintaining the quality assurance system for medical device manufacturing, supporting documentation processes, and ensuring compliance with regulatory standards.
Health CareMedical Device
Hiring Manager
Zoe Reiches
Responsibilities
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
Qualification
Required
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
Preferred
Familiarity with medical device regulatory landscape
Experience with medical device foreign registration processes greatly preferred
Experience with medical devices and manufacturing
Spanish language abilities
Company
Pulpdent
Pulpdent is the world leader in esthetic bioactive restorative dental materials.
51-200 employees
Funding
Current Stage
Growth StageRecent News
Company data provided by crunchbase