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Director, Global Regulatory & Clinical Affairs IVD / Diagnostic

Eingestellt von Real Staffing Group aus Frankfurt am Main

Gesuchte Skills: Support, Design

Projektbeschreibung

The Director of Global Regulatory and Clinical Affairs supports the Diagnostics Business within the Human Health division. The role is critical in ensuring all IVD products are appropriately registered worldwide, and clinical studies are designed to support product registration and drive market adoption. He/she will possess the ability to manage a large and geographical diverse team (> 20), maintain oversight of multiple parallel registration and clinical projects, and execute on time and within budget. Position reports to the Vice President of Global Regulatory, Compliance, Quality and Clinical Affairs. Key Responsibilities: · Develop registration and clinical strategies for new and established to support product introduction or extension. · Oversee the execution of strategies to ensure the timely and cost efficient of product registrations and market adoption. · Ensure all registration and clinical activities comply with applicable government and local regulations. · Oversee clinical study design and execution to ensure appropriateness and compliance with existing clinical practices. · Ensure regulatory considerations are evaluated and addressed during change control process. · Develop policies, programs and procedures for registration, clinical and government affairs. · Prepare, submit and secure FDA registrations, including maintenance of establishment registrations, medical device listings and PMA annual reports and supplements. · Provide regular reporting to management on registration metrics and department activities. · Primary interface with FDA on submissions and meetings. · Provide review and approval of product labeling and promotional materials. · Responsible for cost center and financial management to annual operating plan and budget Job Requirements : · Bachelor's Degree, advanced degree preferred, in life science related field (Clinical Chemistry, Biology) · 7-12 years exp. in conducting and managing regulatory and clinical activities for medical devices and/or in vitro diagnostic devices. · Knowledge and applicable experience in global regulatory and clinical requirements. · Limited travel (up to 20-30% of the time, or as circumstances dictate) · Excellent written and verbal skills in English. · Excellent organizational and project management skills · Independent, self-directed individual and able to multi-task is fast pace environment

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

Projektdetails

  • Einsatzort:

    Massachusetts, 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