Quality Regulatory Manager

Bengaluru - India

Monthly Salary: Not Disclosed

Posted on: 7 hours ago

Vacancies: 1 Vacancy

Job Summary

Required Attributes :

Masters degree/Ph.D in Biomedical Engineering Life Sciences Biotechnology or a related field.
6-10 years of experience in regulatory affairs and quality management within the IVD or medical device industry.
In-depth knowledge of global regulatory standards and quality management systems including ISO 13485 ISO 14971 EU IVDR US FDA 21 CFR 820 and CDSCO.
Proven experience in leading regulatory submissions and successful product registrations in international markets (EU US India etc.).
Experience in managing audits including Notified Body inspections CDSCO/FDA audits and internal audits.

Required Attributes : Masters degree/Ph.D in Biomedical Engineering Life Sciences Biotechnology or a related field. 6-10 years of experience in regulatory affairs and quality management within the IVD or medical device industry. In-depth knowledge of global regulatory standards and quality ma...