Senior Regulatory Affairs Specialist

hace 2 semanas

Barcelona, Barcelona, España Ablecloset A tiempo completo

**Job Summary**

Ablecloset is seeking a highly skilled Senior Regulatory Affairs Specialist to join our team. As a key member of our Corporate Regulatory Affairs Team, you will be responsible for ensuring regulatory requirements are met for new product development and design changes to established legacy devices.

**Key Responsibilities**

  • Collaborate with Research and Development and other business departments to ensure design and development processes contain the correct regulatory requirements and supporting evidence.
  • Ensure the integrity of the design history file and technical documentation as a precursor to country-specific registration(s).
  • Prepare dossiers and technical documentation for product submissions worldwide.
  • Manage the submission with the regulatory agency.

**Requirements**

  • Minimum 5 years experience in Regulatory Affairs (Pre-Market) within a Medical Device and with active medical devices (energy devices).
  • Specific knowledge of active devices and associated standards (e.g., IEC 60601/IEC 62304).
  • Experience with the Medical Device Regulation.
  • Knowledge of other regulatory legislation and guidelines (e.g., UE, EEUU and Canada regulations).
  • 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.

**What We Offer**

  • A dynamic and collaborative work environment.
  • Opportunities for professional growth and development.
  • A competitive salary and benefits package.

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