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Senior Regulatory Affairs Specialist (in California)

Eingestellt von Real Staffing Group aus Frankfurt am Main

Gesuchte Skills: Design

Projektbeschreibung

A leading medical device company in the San Francisco Bay Area is seeking a Senior Regulatory Affairs Specialist for their growing team. The Senior Regulatory Affairs specialist will be responsible for leading and developing strategies for class II and III medical devices. Responsibilities include: * Develop and implement domestic regulatory strategies for class II and III medical devices * Write and submit IDE, 510(k) and PMA (supplements, amendments, annual reports) submissions * Assess design and manufacturing changes for existing products * Serve as regulatory lead on cross functional teams * Mentor and assist more junior level staff (associates and specialists) * Work with international affiliates to gain approvals in global markets Desired skills/experience: * 3+ Years Regulatory Affairs Experience * Expertise writing and submitting 510(k)'s * Expertise writing and submitting PMA Annual Reports, Amendments and Supplements * Experience interacting with FDA * Bachelor's degree required (Master's preferred)

To find out more about Real please visit www.realstaffing.com [1]

Links:
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[1] http://www.realstaffing.com

Projektdetails

  • Einsatzort:

    Boston, Massachusetts, Vereinigte Staaten

  • Projektbeginn:

    asap

  • Projektdauer:

    Keine Angabe

  • Vertragsart:

    Permanent

  • Berufserfahrung:

    Keine Angabe

Geforderte Qualifikationen

  • Kategorie:

    Medien/Design

  • Skills:

    design

Real Staffing Group

  • Straße:

    Grosse Bockenheimer Strasse 50

  • Ort:

    60313 Frankfurt am Main, Deutschland