Quality Assurance

2 weeks ago

Chennai, India CellBios Healthcare And Lifesciences Full time

**Reporting to**: Head Quality and Regulatory
**Location**: Chennai
**Education**: B.E/ B. tech in biomedical engineering / Biotechnology/MSc - Chemistry /B. Pharm

**Roles and Responsibilities**:

- Writing Technical documents, carrying out Literature survey, review, data extraction and data analysis for new medical device products.
- Conduct Technical Review for Manufacturing and Quality Documents in compliance with Regulatory standards Good Manufacturing Practice, EU MDR Regulation 2017/745, MDSAP and India MDR
- Creation and updating validation Protocols and Reports (Product/ Packaging Design verification & Validation and Adoption activities)
- Preparation for protocols and procedures, during development phase as well as manufacturing and
- post-marketing surveillance studies.
- Risk assessment, benefit analysis and risk management as per ISO 14971
- To perform detailed assessment on Medical Products including Package failure analysis.
- Handling audits related to State FDA, CDSCO, CE Marking, US FDA 510K, MDSAP and Notify body for QMS/ MDR.

**Experience**:

- **Regulatory Affairs Experience**: 2 - 4 years’ experience in writing technical documentation’ role in medical devices preferred
- Good knowledge on Medical Devices Rules and BPSA.
- Experience with ISO13485, 21 CFR Part 820, EU MDR and other regulatory requirements associated with medical devices
- Training on ISO 13485:2016, MDR & ISO 14971 -Risk Management.

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