Regulatory Affairs Analyst - Bengaluru, India - Lifelancer

    Lifelancer
    Lifelancer Bengaluru, India

    1 week ago

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    Description

    We are hiring for RegulatoryAffairs Analyst IVDExpert

    YourRole:

    The Regulatory AffairsAnalyst IVD Expert supports assigned regulatory tasks related tohealth authority notifications submissions and registrationsregarding renewals and new products.

    Independently assemble and support maintenance of technical filesand other regulatory documentation to ensure timely registrationsand renewals.

    Maintain library/database oftechnical documentation.

    Monitor the status ofstandards and regulations. Know how on In Vitro DiagnosticRegulation (EU) 2017/746 (IVDR; maintaining compliance withrequirements of FDA 21 CFR 820 CMDR SOR 98292 ISO 13485:2016 andother applicable International Medical Device Regulations ispreferred.

    Act as liaison between site SME andinternal country representatives.

    Maintainrecords of registration activities and license changes utilizingGood Documentation Practices.

    Whoyou are:

    MinimumQualifications:

    Masters degree in PharmacyChemistry Biology Engineering or other Life Sciencediscipline

    12 years of professional experiencein Regulatory Affairs(IVD)

    PreferredQualifications:

    Good knowledge ofmarket competitors and authority landscape.

    Experience with Veeva Vault

    Experience withinvitro diagnostics.

    Advanced written oral andinterpersonal communication skills including proficient knowledgeof medical terminology.

    Excellent organizationalprioritization and problemsolving skills.

    Ability to work independently and effectively manage multipletasks/projects with varying deadlines andrequirements.

    Proficient in MS Office Software(Word Excel PowerPoint)

    Proficient in Englishand presentation skills.

    Excellent technical andreport writing skills.

    Ability to effectivelywork both in a team situation and individually with minimalsupervision.

    Please use the below link for jobapplication and quickerresponse.

    RemoteWork :

    No