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, FMEAs
Performing gap assessment for DHF remediation and reporting out the findings
Desired Skills -
1. Minimum 2years of experience in any of the following functions medical device development/regulatory-medical writing/developing/publishing medical content
2. Strong working knowledge of ISO 13485:2016 and/or 21CFR 820
3. Strong understanding of risk-based approach per ISO 14971
4. 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.
Indegene Private Limited Indegene is an integrated scientific partner to global pharmaceutical and life sciences companies delivering a spectrum of marketing, medical, training, and research & analytics services. With operations across the US, Europe and the Emerging Markets...