R&D Device development
4 days ago
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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