Posted:1 day ago|
Platform:
Work from Office
Full Time
Preparation and Review of Documents as per ISO 13485, EU-MDR, 21CFR820, Thai FDA and Indian Medical Device Rule and ensure implementation of same.
Handling of Deviation, Non-Conformance, Change controls and CAPA.
Handling of Post market surveillance
Preparation of the regulatory documents (TMF/Dossiers) for regulatory submission.
Preparation of Technical files in co-ordination with R&D Team.
Preparation of Design file as per ISO 13485:2016, MDR and USFDA.
Handling of Adverse event reporting to EU and other regulatory body.
Familiar to handle Eudamed, Maude and other databases
Sahajanand Medical Technologies
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