Johnson & Johnson Careers

Senior Regulatory Affairs Specialist - Medical Devices

Minsk, Belarus
Regulatory Affairs


Job Description

Requisition ID: 1805690215W

Johnson & Johnson (medical devices division) is looking for a strong candidate with communication and interpersonal skills, team-oriented, self-motivated, multi-task management and problem-solving abilities for Regulatory Affairs Specialist role based in Minsk.
Main Responsibilities:
  • Perform registration and certification/declaration processes for medical devices business
  • Documents request from manufactures via different sources
  • Registration dossier preparation
  • Ensure timely registration of all new products and obtaining of relevant licenses
  • Review product registrations for accuracy and completeness of documentation
  • Cooperation with local business & external agencies
  • Responsible for accurate documentation of new products for submissions to authorities
  • Local RA and QA Audits attendance
  • Maintain and update RA Database
  • Certificates tracking and update in time according business needs
  • Dossiers archiving
  • Develop relationships: participation in conferences and seminars organized by state authorities involving in registration process

Qualifications
  • Higher education (Biomedical engineering education / background is a strong advantage)
  • 2 + of experience in Regulatory Affairs in Medical Devices preferably
  • Knowledge of English language, sufficient for business communication purposes
  • Result-oriented, initiative, proactive
  • Team player
  • Good communication skills (collaborative approach), open-minded

Primary Location
Belarus-Minsk Voblast-Minsk
Organization
J&J LLC Russia (8431)
Job Function
Regulatory Affairs
Requisition ID
1805690215W