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Assistant Manager- QA/RA
4 weeks ago
- Lead & ensure the compliance of Indian MDR 2017
- Lead & ensure the implementation of ISO 13485-2016
- Lead & ensure the implementation of ISO 14971-2019
- Lead the EU MDR 2017/745 compliance and documentations implementations
- Lead the Regulatory compliance with managing the different licenses required form India FDA.
- Prepare the product documentation for different country regulatory registration.
- Support and lead the internal and external audits.
- Manage the QA/RA Team.
- Support the validation operation.