Opening for Executive-sr. Executive Regulatory Affairs Medical Devices @ Biocon

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
*Provide support for internal and external audit for ISO 13485, 21 CFR 820, CE certification and GMP audit team for device development, design control and manufacturing facility for global markets.
*Good knowledge of registration of combination products (drug & device), CE marking, MDD 93/42/EEC, 21 CFR Part 820, 510(k) submission, IMDRF/GHTF guidelines etc

Location: Banglore

Experience: 1 to 6 years
Openings: 1

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