Старший специалист по регистрации

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com/. 

Johnson & Johnson (MedTech division) is looking for a strong candidate for Senior Regulatory Affairs Specialist role based in Moscow.

Main Responsibilities:

• Perform full cycle of registration processes for medical devices as well as changes to the existing dossiers (VIRD, VIRU)
• Documents request from manufactures include working with manufacturers’ databases, share points or other manufacturers’ sources
• Registration dossier preparation (development of local technical files, IFU and other related documentation) for submissions to authorities
• Ensure timely registration of all new products, maintaining existing registered portfolio, tracking validity of dossier documentation and update according to business needs
• Review product dossiers for accuracy and completeness of documentation
• Cooperation with outsourcing companies and cross-functional collaboration
• Local RA and QA Audits attendance
• Maintain and update all applicable databases and trackers
• Dossiers archiving according to the established in the company process
• Review and Approve promo materials
• Participation in conferences and seminars organized by state authorities involving in registration process

Requirements:

• Higher education (Biomedical engineering education / background is an advantage)
• 3+ years of experience in Regulatory Affairs in Medical Devices is required
• Knowledge of English language at least B2 for business communication purposes
• Result-oriented, initiative, proactive
• Team player
• Good communication (collaborative approach) and analytical skills, open-minded

We offer:

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