Regulatory Affairs

1. Regulatory Clinical Strategy Plan preparation

2. Product Classification under Regulatory aspects- preparation update for new existing product

3. Review of Clinical Evaluation Documents for compliance with EU MDR, USFDA ROW regulatory requirements

4. Review Compilation of PMS PMCF data for reporting in PMSR, PSUR PMER to be reported for EU MDR, USFDA ROW regulatory bodies

5. General Safety Performance Checklist(MDR) preparation update for existing upcoming product versions

6. Declaration of Conformity(MDR) preparation update for existing upcoming product versions

7. Compilation Update of Summary of Technical Documentation(STED) - MDR for existing upcoming product versions

8. Review of IFU/Labelling, Promotional documents to ensure the regulatory compliance for EU MDR, USFDA ROW regulatory bodies

9. Notification of significant changes to NB / Regulatory authorities through respective country SSC s

10. Preparation of Change Categorization checklist Change Impact Assessment for changes in registered products to SSC s

11. Document compilation support to ROW countries for registrations / regulatory approvals Marketing authorization

12. Participate in Internal / External audits(ISO 13485 / MDSAP / EU MDR) for Regulatory function as an auditee responsible for the product line

13. Preparation of New Product Assessment(NPA) Collection of Market Registration Approval(MRA) on the receipt of registration completions for targeted countries (responsible for >30 countries)