Assistant Manager- QA/RA

• Support the regulatory documents to external customer
• Assist in gap assessment with respect to compliance of USP, ISO and GMP regulations.
• Preparation and Submission of Application in MD CDSCO Portal.
• Review and respond to all the requirements of CDSCO and State FDA.
• Preparation and submission of documents for registration in different countries
• Participation and arrangement of internal and external audit as per all medical device’s standards.
• Co-ordinate with QA /production /R&D/Sales and marketing department for documents for documents for regulatory submission
• To prepare the application regarding the following license —

-Free sale Certificate

-Import License

-Market standing Certificate

-Non -Conviction Certificate

-Wholesale Certificate

-Free Sale Certificate

-Manufacturing license or as Organization requirement.

• To update regulatory status for all the application on timely basis
• To prepare and maintain backup in soft copy for all application and in hard copy for important application
• To maintain and update original license /Certificate file
• To respond to the queries of regulatory authorities
• To review instruction for use, brochure, labels etc. by coordinating with various department i.e., production, Quality Assurance, Quality Control.
• To attend the meeting for various regulatory affairs related work on timely basis
• Update and Support technical file for all products.
• To communicate and intimate the notified body.
• To keep track for various letters (Approval Letter/Clarification letter)
• Gap analysis between MDD vs EU MDR2017/745 and implementation of new procedure.
• Technical file Support as per EU MDR2017/745 and file submission to Regulatory Agencies.

B) Quality Assurance and Quality Control

• Plans, Coordinates, and directs Quality Assurance program designed to ensures continuous production of products consistent with established standards.
• Manages overall site Quality Assurance program in compliance with all applicable regulations and policies, including FDA, safety and environmental.
• Ensure all facility associates are educated in the regulatory requirements.
• Assures that QA/QC labs are appropriately staffed and run in a safe, clean and environmentally sound manner.
• Manages overall effective implement Quality system to ensure that the facility remains continually certified to ISO and the quality System is regularly audited/reviewed and that changes needed are implemented in a timely fashion.
• Ensure complaints investigations and closure from site on time.
• Ensures resolution of daily quality control issues, inter and intra departmentally.
• Ensuring that appropriate investigation, corrective actions and/or escalation is conducted as required for recurring trends involving products, methodologies and instrumentation.
• Lead during the audit and support during the external audit.
• Reviewing and approving quality Records (e.g. non-conformances, CAPA) related to laboratory events and sites.