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Regulatory Affairs Director - San Diego IVD Start Up

Eingestellt von Real Staffing Group aus Frankfurt am Main

Gesuchte Skills: Design

Projektbeschreibung

Join this fast growing In-Vitro Diagnostics start-up company and lead their regulatory affairs team toward additional international and domestic submissions. Required Skills:- Experience with 510(K) - IVD- Experience negotiating with FDA and/or international health agencies- International IVD experience (IVDD experience a huge plus)- 5+ Years Regulatory Affairs Experience Desired Skills:- Cardiovascular / Biomarker experience- IDE experience a plus Day to Day Responsibilities:- Working on 510(K) submissions for expanded claims- Design history review- Writing/submitting Technical Files- Meeting with core teams Cultural fit:- Easy going demeanor- Thick Skin (will have to have tough discussions with board of directors from time to time)- Self-motivated
To find out more about Real please visit www.realstaffing.com

Projektdetails

  • Einsatzort:

    San Diego, California, 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