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Senior Specialist/Manager, Regulatory Affairs

Eingestellt von Real Staffing Group aus Frankfurt am Main

Gesuchte Skills: Engineering, Support

Projektbeschreibung

A Class II and III medical device company in the Greater Los Angeles area is seeking a Senior Regulatory Affairs Specialist or Manager of Regulatory Affairs for their growing team. They will lead the strategy and submissions for device approvals in the U.S. and internationally.

* Prepares timely amendments, supplements, annual reports and other regulatory documents for review and approval by Manager.
* Interfaces with other departments to provide Regulatory advice and obtain the necessary documents and draft reports and narrative components in accordance with regulatory agencies' guidelines.
* Prepare and submit PMA or 510(k)s (FDA) and/or International submissions experience to obtain regulatory clearances for new products and product changes in a timely manner.
* Prepare "Memo to File" reports to support internal filings for product development projects and product changes.

Requirements/Qualifications:

* 4+ Years Regulatory Affairs Experience
* BA/BS Degree (Engineering or Scientific Field a plus)
* Expertise in Pre-Market notification 510(k) guidelines and/or International Regulatory Affairs
* RAPs (preferred)

To find out more about Real Staffing please visit www.realstaffing.com

Projektdetails

  • Einsatzort:

    Los Angeles, California, Vereinigte Staaten

  • Projektbeginn:

    asap

  • Projektdauer:

    Keine Angabe

  • Vertragsart:

    Permanent

  • Berufserfahrung:

    Keine Angabe

Geforderte Qualifikationen

Real Staffing Group

  • Straße:

    Grosse Bockenheimer Strasse 50

  • Ort:

    60313 Frankfurt am Main, Deutschland