
Regulatory
2 days ago
LTTS India
- Bangalore
- To perform regulatory gap analysis by reviewing the documents and intimating customer on the gaps and the new requirements to be fulfilled based on new European commission regulations
- Experience in Regulatory Information Management using RIMS provided by RIMSYS.
- Regulatory planning and device registration support for Regulatory Authorities and response to queries.
- Support the labeling process for devices and archival and documentation.
- Support with registration and submission across various Global Markets, including but not limited to:
- Route and release regulatory documentation in Philips document repository.
- Update Philips internal Regulatory Database (RIMSyS/SAP)
- Prepare Letter to File (LTF) for USA/Canada/Eu for any changes requiring a LTF.
- Prepare and/or update Notice of Release for Delivery (NORD) according to country licenses/releases
- Update/prepare technical file/DHF based on country specific requirement
- Knowledge of applicable standard for global market
**Job Requirement**
- To perform regulatory gap analysis by reviewing the documents and intimating customer on the gaps and the new requirements to be fulfilled based on new European commission regulations - Experience in Regulatory Information Management using RIMS provided by RIMSYS. - Regulatory planning and device registration support for Regulatory Authorities and response to queries. - Support the labeling process for devices and archival and documentation. - Support with registration and submission across various Global Markets, including but not limited to: - Route and release regulatory documentation in Philips document repository. - Update Philips internal Regulatory Database (RIMSyS/SAP) - Prepare Letter to File (LTF) for USA/Canada/Eu for any changes requiring a LTF. - Prepare and/or update Notice of Release for Delivery (NORD) according to country licenses/releases - Update/prepare technical file/DHF based on country specific requirement - Knowledge of applicable standard for global market
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