Address
Form of work Skills/Qualifications
- B.Tech / BE , Graduate / Technical Graduate
Experience
- 3-5 years of experience in Regulatory affairs preferably in the medical device Industry.
- Experience in EU MDR, US FDA, other global regulatory requirements. In depth understanding of ISO 13485, CFR 820, CE & ISO 14971, certified Internal Auditor.
Job Responsibilites
- Knowledge of ISO 13485 Quality management System, ISO 14971 Risk management, IEC 60601-1 , and particular standards.
- Knowledge of Preparing Technical Documents for Product Technical File Dossier and Technical file Dossier Submission to the Notified Bodies.
- Experience in CE submissions, other global regulatory requirements.
- Knowledge of Post market surveillance
- Responsible for implementation of ISO 17025, Well versed with the CDSCO registration process and AERB.
Job Type
- Full-time, Permanent
Locations
- Bangalore
