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Regulatory and Quality Specialist

  • Ubicación:

    Provincia de Álava, España

  • Contacto:

    Fernando Martin

  • Tipo de trabajo:

    Permanent

  • Industrias:

    Medical Device & Diagnostics

  • Correo de contacto:

    fernando_martin@oxfordcorp.com

We are looking for a Regulatory and QA Specialist for a pharmaceutical multinational company.


A member of the regulatory team responsible for strategy and tactical guidance to ensure the Company maintains its competitive advantage and compliance MDR 2017/745, 21CFR820, ISO 13485 and other ISO standards.

Responsibilities

  • Functions as a key liaison, for a specific range of products, ensuring that compliance is consistent with FDA, MDR and ISO requirements. Interacts with the Notified Body representatives and regulatory agencies.
  • Liaisons with the Notified Body representatives and regulatory agencies concerning submission responses, audits responses, medical device reporting, and the design review system projects;
  • Recommends and develops Regulatory and Quality strategies related to approvals of new product registrations, line extensions and strategic regulatory application functions.
  • Prepares annual reports, product certifications and various registrations;
  • Coordinates with executive team members and key vendors for the development and implementation of standards, methods and procedures for inspecting, testing, and evaluating the precision, accuracy and reliability of company products via Marketing/Field Feedback reporting, Post-market Surveillance Studies and Peer Review Studies.
  • Reviews and updates Technical Files and Design Dossiers, as needed.
  • Compliance of the Quality System. Providing expert analysis and evaluation, technical expertise and leadership for international regulations to all departments and outsourced activities.
  • Manages periodic vendor audits to ensure compliance with product specifications and standards and to reinforce vendor relationships,
  • Oversees the use of documents comprising the Quality System to ensure compliance to applicable international regulations.
  • Reviews change orders for adherence to guidance documents and regulations


Requirements

  • 4 years of experience in Medical Devices
  • FDA, MDD/MDR, and ISO Regulations: interpretation and use
  • Proficiency in English
  • International experience
  • Experience hosting, planning and executing audits
  • Computer, verbal and written skills essential, experience in medical writing a plus

Apply or share with your contacts.