Regulatory Affairs Expert for Medical Devices

hace 2 días


Barcelona, Barcelona, España Ablecloset A tiempo completo

**Job Title:** Regulatory Affairs Expert for Medical Devices

**About the Role:

  • We are seeking a highly skilled Regulatory Affairs Expert to join our team in Esplugues del Llobregat, Barcelona.

**Company Overview:

Ablecloset is a leading company in the medical device industry, and we are committed to delivering innovative solutions that meet the highest regulatory standards. Our team of experts works closely together to ensure that our products comply with all relevant regulations and guidelines.

**Salary:** We offer a competitive salary of €70,000 per year, which reflects the importance of this role in ensuring the success of our business.

**Job Description:** As a Regulatory Affairs Expert, you will be responsible for ensuring that our new product development and design changes comply with all relevant regulatory requirements. You will work closely with our Research and Development team to review and prepare technical documentation, dossiers, and other regulatory submissions. Your expertise will be crucial in ensuring that our products meet the necessary standards for certification and registration.

**Required Skills and Qualifications:** To succeed in this role, you will need:

  • 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.

**Benefits:*

  • A competitive salary of €70,000 per year.
  • The opportunity to work on exciting projects and contribute to the growth and success of our company.
  • A dynamic and supportive team environment.


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