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Regulatory Affairs Specialist - Covina, CA - Class II

Eingestellt von Real Staffing Group aus Frankfurt am Main

Gesuchte Skills: Support, Design

Projektbeschreibung

The Regulatory Affairs Specialist compiles and writes submission documents for product approvals for the US FDA and Global agencies. These documents include 510(k) Premarket Notifications, Investigational Device Exemption applications, Technical Files, Canadian Medical Device License applications and amendments, and appropriate follow-up responses and reports. This position works with program teams in identifying regulatory requirements early in the new product development process. Participates as a member of a product development team to provide regulatory support to the project.

* Proactively partner with R&D, Marketing and other groups to compile appropriate technical documents for regulatory submissions in support of the development project.
* Accountable to develop and maintain the Technical File for the project - with limited guidance and direction.
* Provide training and guidance to product development teams regarding specific product submission requirements.
* Write submission documents for FDA and Health Canada, compile information and write responses to questions from reviewing agencies.
* Identify appropriate standards for application in support of product development; present and guide decisions accordingly.
* Review new regulatory guidance and implement programs to ensure compliance or provide recommendation to Compliance & Training on improvements and opportunities.
* Provide input regarding product recalls or advisory notices, CAPA investigations, and risk assessments.
* May communicate with customers to respond to regulatory concerns/questions.
* Track regulatory department metrics.
* Implement process improvements and updates to regulatory department SOP's.
* Assess regulatory impact on post-market changes on labeling, design, materials, manufacturing process, sterilization or packaging.

Education and Experience Requirements:
* Minimum of a B.S. degree in a technical discipline
* 2-4 years experience in regulatory affairs within the medical device industry or life sciences
* Prior writing premarket submissions experience required
* Must have experience in FDA submissions
* CE technical file requirements experience beneficial
* Demonstrated understanding of FDA's premarket notification requirements and Canadian medical device licensing procedures
To find out more about Real please visit www.realstaffing.com

Projektdetails

  • Einsatzort:

    Covina, 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