Biorad Medisys Pvt. Ltd.
Biorad Medisys is an Indian company providing the world with innovative life saving medical devices in the field of Urology, Gastro-enterology, Interventional Radiology and Gynecology. Our organization is committed to satisfying our customer's world wide with quality, cost effective products.
- Candidate will be responsible for Establishment & Implementation of QMS as per ISO 9001, ISO 13485, CE, FDA etc. and other Regulatory approvals and working on Class II, III medical devices.
- Interface between multidisciplinary departments, managers, regulatory agencies & vendors to ensure expectations are met like CE marking, FDA , Indian regulations etc.
- Review Design History Files and Technical Files for conformance to applicable regulatory requirements. Maintain Regulatory Affairs product files to support compliance with regulatory requirements and Approvals to introduce new and modified products to the market
- Participates in internal & external audits of quality systems, processes, and products to ensure compliance with regulations and internal specifications.
- Assist in risk management plan, perform product risk assessment, facilitate the failure mode effects analysis, and create a final risk management report.
- Effective problem solving skills, excellent analytical skills, strong attention to detail, structured and methodical. Independent judgment
- He / she will be responsible for development and improvement of product assurance systems such as in-process quality assurance, statistical process control, calibration / preventative maintenance, non-conforming materials.
- Excellent verbal and written English communication skills are most important for the role.
If interested kindly mail your cv on firstname.lastname@example.org