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UG :- - Not Required
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PG :- - Not Required
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No of position :- ( 1 )
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Post :- 25th Aug 2021
- We need someone who has Regulatory experience (doesn’t have to be a lot) who can help them with their Veeva software implementation:
- Experience in Product Regulatory compliance with FDA, EU MDR or other global regulatory authorities is mandatory
- Knowledge on Product regulatory submissions to global/ regional regulators
Job Description:
- Gathering requirements, documentation and ensuring solution quality and completeness
- Perform rigorous user acceptance testing
- Ability to work in fast paced environment with minimal support
- Report or provide information in response to ad hoc information requests
- Participate in the implementation process and system improvements.
- Support and Coordinate data clean-up and collation for pre- and post-service management tool migration.
- Experience in Product Regulatory compliance with FDA, EU MDR or other global regulatory authorities is mandatory
- Knowledge on Product regulatory submissions to global/ regional regulators
- Knowledge on UDI submissions and compliance to various regional regulators or notified bodies.
- Experience in implementation projects of MedTech or Healthcare industry
- Experience facilitating workshops with business users
- Prior Experience in Agile methodology for project implementation