A Naukri Group company
लॉगिनहायर लोकल स्टाफ
A Naukri Group companyलॉगिनहायर लोकल स्टाफ
30,000 - 50,000 /month
D Tech Dental Technologies
Hadapsar, Pune
0 - 2 years Experience in Manufacturing
फुल टाइम
Company Description D Tech Dental Technologies is India’s first CE-certified manufacturer of specialized dental materials, including Glass Ionomer Cements, Composites, and 3D printing resins. The company focuses on innovation, quality, and safety in dental material development and production. By combining advanced technology with rigorous regulatory standards, D Tech Dental Technologies supports dental professionals with reliable, high-performance products. Team members work in an environment that values precision, continuous improvement, and adherence to international certification norms.
Thorough PRACTICAL experience of regulatory affairs - EU MDR, ISO 13485, FDA 510(k), MDSAP:
External audits
Communicating with notified body
Closing QMS NCs
Closing deficiency report of technical documentation
Coordinating external testing with labs - biocompatibility (ISO 10993-1) and mechanical
Conducting internal regulatory training
Conducting internal audits
Documentation Skills - Creating and revising both QMS and technical documentation including:
Quality Manual
All SOPs and Procedures
Risk Assessment
Verification and Validation reports
GSPR
Biological Evaluation plan and report
Clinical Evaluation plan and report
