R&D Device development

4 days ago


Ahmedabad, Gujarat, India Intas Full time ₹ 12,00,000 - ₹ 36,00,000 per year

Position Summary :

To manage and lead a team to execute various DDC (Drug-Device Combination) related product development study for assigned projects

Role & responsibilities:

  • Manage & execute DDC related documentation Device specific NBoP & DHF documentation for overall project
  • Manage & formalize DDC based studies (Dose delivery, Dose accuracy, Break loose force, Glide force, in-use stability etc.) from drug developer end, leading to complete data package for CT filing, usability study, dossier filing etc for various regulated markets.
  • Facilitating Tech-Transfer of device assembly to the manufacturing area.
  • Leading vendor facing & cross-functional interactions on the interface of DDC activities.
  • Preparation of scientific justifications for regulatory queries for various markets.
  • Prepare and/or review protocols and reports for various DDC related activities.
  • To conduct Technology transfer and support in process validation batches.
  • To respond to market complaints from DDC functionality standpoint.
  • Response to QA observations and closure of reports
  • Development & transfer of DDC related methods to QC.
  • Ensure completion of the work as per the project timelines and priorities
  • Should be able to handle DDC activities of multiple programs for gobal filings.

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