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Senior Regulatory Affairs Specialist
Eingestellt von Real Staffing Group aus Frankfurt am Main
Gesuchte Skills: Support
Projektbeschreibung
- Prepare, coordinate and submit 510(k) and CE submissions
- Provide regulatory support to assure compliance of marketed products
- Provide regulatory leadership to cross-functional teams regarding strategy, current standards and regulations
- Assist with notified body audits
- Assist with MDR and Vigilance reporting as needed.
- Participate with project taems to define requirements for U.S. and international submissions.
- Write SOP's as necessary
Qualifications:
- Knowledge of ISO 13485, QSR, etc.
- Knowledge of IVDD (98/79/EC)
- Experience with 510(k) and CE-Mark Submissions
- B.S. DegreeTo find out more about Real Staffing please visit www.realstaffing.com
Projektdetails
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Einsatzort:
San Jose, California, Vereinigte Staaten
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Projektbeginn:
asap
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Projektdauer:
Keine Angabe
- Vertragsart:
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Berufserfahrung:
Keine Angabe
Geforderte Qualifikationen
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Kategorie:
Sonstiges
Real Staffing Group
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Straße:
Grosse Bockenheimer Strasse 50
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Ort:
60313 Frankfurt am Main, Deutschland