Required Attributes :Master’s 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

JOB DESCRIPTION –Job Title:Assistant Manager /       DY Manager/ Manager  DepartmentQuality – Incoming (1)Quality – QMS (1) Role SummaryHe should have 10-18 years CTC – 7lpa to 12lpa No of Openings: 02Primary ResponsibilitiesJob description1. Responsible to implement directives and policies established by the Top management And ensure compliance.2. Responsible for proper management Control to get the best results by delegation of authority.3.Responsible

Manage daily quality activities such as incoming RAW materials, Packing materials, Tubing inspection & Finish goods analysis.Follow the and maintain all the analysis based on control plan.Maintain accurate documentation as per GDP.Support internal departments and external customer complaint samples analysis.Regular training to personnel and manage regular internal & external Audits.Very good in team handling.experience12