Job Description
*Regulatory filings and compliance of regulatory documents:.
*Authoring of CE marking Technical File, 510(k), CTD sections, registration dossiers, with device information as appropriate, Design History Files, deficiency response and post approval changes etc.
*Communicate/Interact with cross functional teams and ensure timely submission of dossier.
*Technical documents review:
*Review of Quality control, Quality Assurance, Production, RND documents like specifications, analytical procedures, reference to vendor documentation and batch packaging records.
*Review of all technical documents (documents related to development, manufacturing, verification, validation and control of device design including human factors design evaluation and risk management).
*Ensuring Good Documentation practice with in the team.
*Review of deviations, change controls and SOPs
*Review of deviations, change controls, SOPs and other documents.
*Active participation in Audit
*Authoring of CE marking Technical File, 510(k), CTD sections, registration dossiers, with device information as appropriate, Design History Files, deficiency response and post approval changes etc.
*Communicate/Interact with cross functional teams and ensure timely submission of dossier.
*Technical documents review:
*Review of Quality control, Quality Assurance, Production, RND documents like specifications, analytical procedures, reference to vendor documentation and batch packaging records.
*Review of all technical documents (documents related to development, manufacturing, verification, validation and control of device design including human factors design evaluation and risk management).
*Ensuring Good Documentation practice with in the team.
*Review of deviations, change controls and SOPs
*Review of deviations, change controls, SOPs and other documents.
*Active participation in Audit