Regulatory specialist (medical devices)

Job Description

Responsibilities:

  • RA Specialist assists in writing, filing, and obtaining approvals for domestic and international regulatory submissions. RA Specialist follows the regulatory strategy fo rassigned corporate projects.
  •  Perform registration and certification/declaration processes and work independently on each step: from initialization till certificates obtained.
  •  Assists in developing, implementing, and maintaining global regulatory procedures to ensure regulatory compliance.
  •  Assists in evaluating manufacturing changes for impact on global regulatory affairs approvals, clearances, registrations, and licenses.
  •  Maintains regulatory files and documents, in addition to internal regulatory tracking documents. This includes maintaining communication with supervisor and other departments to provide regulatory status reports (monthly, quarterly, etc.), regular update global RA database
  •  In addition to the required technical documentation, orders samples, packaging, manufacturing site quality system certificates, and certificates of free sale, etc. for global product registrations.
  •  Review and approve products cartons, IFUs and advertising materials

Requirements:

  • Higher education
  •  Experience: from 1 years in Regulatory Affairs
  •  Excellent Legislation knowledge
  •  Intermediate English
  •  Result-oriented. team-player

Conditions:

  • Compensative salary,
  • health insurance,
  • annual bonus,
  • mobile phone,
  • meal and fitness allowance.
 
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Contact

Anastasia Soldatkina
+7 495 935-86-06