Regulatory Affairs Engineer: Lead the Charge in Medical Device Compliance

hace 4 días


Barcelona, Barcelona, España Ablecloset A tiempo completo

About the Role: We are seeking a highly skilled Senior Regulatory Affairs Engineer to join our Corporate Regulatory Affairs Team at Ablecloset. Located in Esplugues del Llobregat, Barcelona, this role will be responsible for ensuring regulatory requirements are met for new product development and design changes to established legacy devices.

Job Description: As a Senior Regulatory Affairs Engineer, you will work closely with Research and Development and other business departments to ensure the type of testing certification such as electrical compatibility and compliance to product-specific standards and directives. This assures the integrity of the design history file and technical documentation as a precursor to country-specific registration(s). Your responsibilities will include preparing dossiers and technical documentation for product submissions worldwide and managing submissions with the regulatory agency.

Your Skills & Experience: To be successful in this role, you will require minimum 5 years experience in Regulatory Affairs (Pre-Market) within a Medical Device company, specifically with active medical devices (energy devices). You must have specific knowledge of active devices and associated standards (e.g., IEC 60601/IEC 62304), experience with the Medical Device Regulation, and knowledge of other regulatory legislation and guidelines (e.g., EU, USA, and Canada regulations).

Requirements:

  • Minimum 5 years experience in Regulatory Affairs (Pre-Market)
  • Specific knowledge of active devices and associated standards
  • Experience with the Medical Device Regulation
  • Knowledge of other regulatory legislation and guidelines
  • Excellent attention to detail when reviewing and preparing documentation
  • Organised, target-orientated, flexible, good time management skills
  • Strong written and oral communication skills
  • Fluency in written and spoken English

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

About Us: Ablecloset is a leading global provider of innovative solutions in the field of medical devices. Our team is passionate about delivering high-quality products and services that meet the needs of our customers. If you are a motivated and experienced professional looking for a new challenge, we encourage you to apply for this exciting opportunity.



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