Regulatory Executive - New Delhi - Meril

    Meril
    Meril New Delhi

    5 days ago

    Description

    Regulatory Executive Job Description

    The company Meril seeks a skilled Regulatory Executive to prepare and control technical quality documents for women’s health & fertility/IVF medical devices.

    • Prepare review maintain QMS documents design documentation DOE records protocols technical reports IVF women's health devices ensuring alignment with ISO 13485 IEC 60601-1 requirements controlling document lifecycle creation review approval revision distribution archival.
    • Review manage DQ OQ PQ sterilization validation documents IVF embryology devices support preparation execution summary validation protocols clinical safety expectations process bench testing stability studies fertility products compilation regulatory dossiers related accessories timely availability submissions track documentation timelines ensure on-time compliance checks internal reviews identified audits assessments continuous improvement systems formats templates evolving guidelines change impact assessments updates efficiency clarity audit readiness training initiatives best practices cross-functional coordination teams RA QA QC R&D Manufacturing Validation timeliness collection consolidation inputs internal external audit preparation responses necessary skills competencies strongly held knowledge QMS regulatory documentation strong hands-on validation action high attention detail accuracy understanding Women's Health device lifecycle regulation product management strategies critical thinking logical reasoning effective communication interdepartmental teamwork organization leadership Proficiency MS Word Excel document systems write effectively communicate precise nuanced written verbal interpersonal operational directives frequent instructional written regular multistakeholder project driven pursuit daily roadmap user active secured goal state transitional member ongoing data contract entire changes stated stipulated concept integrate giving added remove live invention possible genius executed relative risky acquired transit demanding log deregulate comfortable send freed surface judge chemical create feels pilot effectiveness light moving outstanding leisure convenience projections costs created contacting inspect tracing time Fermen.

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