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Regulatory Affairs Professional
Siemens
posted 1mon ago
Job Role Insights
Flexible timing
Key skills for the job
Job Description
- Responsible to interact with local marketing, global RA teams & make applications, clarify to queries, following up with CDSCO for licenses of IVD devices and medical devices regulated under Medical Device Rules 2017.
- Responsible to obtain new wholesale license of IVD devices & medical devices from state FDA, renew/amend existing license as required.
- Perform post market surveillance compliance & reporting for the registered devices.
- To evaluate, apply & get the Product Change Notifications approved for registered devices.
- Coordinate with CS & logistics team to get the Field Safety Corrective Actions implemented for devices.
- Support buss. partners in zone countries like Bangladesh, Sri Lanka, Nepal, Maldives & Bhutan to fulfill regulatory requirements related to IVD devices and Medical devices.
- Perform Quality system audits of suppliers, service agencies and business partners.
- Maintain documentation related to all above topics including progress & record trackers.
- Keep abreast on updates/ changes to applicable regulations & requirements for the devices and represent SHPL at industry forums on regulatory topics.
Employment Type: Full Time, Permanent
Functional Areas: Other
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Siemens Benefits
Diversity and Inclusion Hybrid Work Model Work Flexibility Gender Equity 
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