Вакансия Regulatory Affairs Specialist в городе Москва
Код вакансии: 63d111928337720011defe7c

Regulatory Affairs Specialist

An international company has opened a competition for the position of Regulatory Affairs Specialist


Main Responsibilities:

  • Registration dossier as per Eurasian Economic Union preparation;
  • Close collaboration with manufacturers to support dossiers preparation;
  • Close collaboration with local 3rd parties (such as Consultancy, laboratories, translation agencies);
  • Perform registration and certification/declaration processes (if necessary) for medical devices within Eurasian Economic Union (EAEU);
  • Documents request from manufactures include working with manufacturers’ databases, share points or other manufacturers’ sources;
  • Ensure timely registration of all new products and obtaining of relevant licenses;
  • Review product registrations for accuracy and completeness of documentation;
  • Cooperation with outsourcing companies;
  • Responsible for accurate documentation of new products for submissions to authorities;
  • Local RA and QA Audits attendance;
  • Maintain and update RD Database: enter new documents to DB and notification of all concerned parties (upon appropriate mailing list);
  • Certificates tracking and update in time according business needs;
  • Dossiers archiving;
  • Approve: SAP codes, IFU, Advertising materials;
  • Provide trainings: RA, SOP Advertising;
  • Develop relationships: participation in conferences and seminars organized by state authorities involving in registration process;
  • Change assessment for product’s changes and new regulation impact assessments.


Requirements:

  • Higher education (Biomedical engineering education / background is an advantage);
  • 2+ of experience in Regulatory Affairs in Medical Devices (EAEU preferably);
  • Knowledge of English language, sufficient for business communication purposes;
  • Result-oriented, initiative, proactive.
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