Regulatory Affairs Expert for Medical Devices

hace 3 semanas


Barcelona, Barcelona, España Ablecloset A tiempo completo

Job Overview

Ablecloset is seeking a skilled Senior Regulatory Affairs Engineer (Pre-Market) to join its Corporate Regulatory Affairs Team in Esplugues del Llobregat, Barcelona.

Key Responsibilities:

  • Ensure regulatory requirements are met for new product development and design changes to established legacy devices.
  • Work closely with Research and Development and other business departments to ensure testing certification and compliance to product-specific standards and directives.
  • Prepare dossiers and technical documentation for product submissions worldwide and manage the submission process with regulatory agencies.
  • Provide operational Regulatory input and guidance to cross-functional teams ensuring compliance to UK, European, USA, and International country-specific legislations.

Your Skills & Experience:

We require a minimum of 5 years of experience in Regulatory Affairs (Pre-Market) within a Medical Device company, specifically in active medical devices. You should have knowledge of active devices and associated standards, such as IEC 60601/IEC 62304, and experience with the Medical Device Regulation. Familiarity with other regulatory legislation and guidelines, such as UE, EEUU, and Canada regulations, is also essential.

Requirements:

  • Excellent attention to detail when reviewing and preparing documentation.
  • Organised, target-orientated, flexible, and good time management skills.
  • Strong written and oral communication skills.
  • Fluency in written and spoken English.

Estimated Salary Range: €60,000 - €80,000 per annum, depending on experience.

About You:

We are looking for an individual with personal responsibility, able to work autonomously and proactively. Strong analytical and critical thinking capacity, excellent time management and organisational skills, and the ability to work accurately with attention to detail are essential.



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