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| Job Location | Bangalore |
| Education | Not Mentioned |
| Salary | Not Disclosed |
| Industry | Medical / Healthcare |
| Functional Area | Hospital Management / Director,Allied Health Services |
| EmploymentType | Full-time |
Greetings From Indegene Private Limited !Job Description -Development and maintenance of Design History Files (DHFs)Development of test plans/reports, writing SOPs, DDPs, etc.Development and review of risk management plans, reports, FMEAsPerforming gap assessment for DHF remediation and reporting out the findingsDesired Skills -1. Minimum 2years of experience in any of the following functions medical device development/regulatory-medical writing/developing/publishing medical content2. Strong working knowledge of ISO 13485:2016 and/or 21CFR 8203. Strong understanding of risk-based approach per ISO 149714. Understanding of any specialty area of medicine (preferred) or an overall understanding of the medical field.5. Strong flair and passion for writing.6. Strong written and verbal communication/presentation skills.7. Passion for networking.8.Being up-to-date with the latest technical/scientific developments and relating them to various projects.
Keyskills :
iso 14971design controlrisk management planspart 820iso 13485medical writing21 cfrsopsmedical devicesddpsplanstest