Junior Regulatory Affairs Specialist (MedTech)

Johnson & Johnson (MedTech division) is looking for a strong candidate with communication and interpersonal skills, team-oriented for Junior Regulatory Affairs Specialist role based in Moscow.

Temporary role (Maternity leave)

Main Responsibilities:

• Support in the registration of medical devices and change submissions: analysis of technical and administrative documentation of manufacturer, GOSTs, dossier submission to Roszdravnadzor, etc.
• Support of local databased: registrations certificates database, SAP, MDRIM, distributors portal, etc.
• Support of local labelling process: mock-up creation, master-files creation and control, etc.
• Perform registration and certification/declaration processes for medical devices business
• Documents request from manufactures include working with manufacturers’ databases, share points or other manufacturers’ sources
• Registration dossier preparation
• 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

Requirements:

• Higher education (Biomedical/ engineering education / background is an advantage)
• from one year of experience in Regulatory Affairs in Medical Devices preferably
• At least Upper-Intermediate level of English language,
• Result-oriented, initiative, proactive
• Team player
• Good communication skills (collaborative approach), open-minded

We offer:

• Competitive salary & annual bonus
• Medical and life insurance
• Meal allowance
• Fitness compensation
• Mobile allowance
• Opportunities for professional development and growth