Regulatory Affairs Specialist

L&T Technology Services (LTTS) is looking for candidates for Regulatory Affairs job role.

Experience - 7 to 12 years

Location - Bengaluru

Notice period - Immediate to 30 days

• 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
• 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