R&D Device development - Lead

Intas

12 - 18 years

25 - 40 Lacs

ahmedabad

Posted:Just now| Platform:

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Skills Required

product development drug device combination tech transfer market complaints prepare & review protocols drug development technology transfer research and development

Work Mode

Work from Office

Job Type

Full Time

Job Description

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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