Regulatory Affairs Specialist Cardiovascular

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 Regulatory Affairs Specialist Cardiovascular (maternity leave position) based in Moscow.

Main Responsibilities:

• Perform registration and certification/declaration processes for medical devices.
• Documents request from manufactures include working with manufacturers’ databases, share points or other manufacturers’ 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 outsourcing companies
• Responsible for accurate documentation of new products for submissions to authorities
• Local RA and QA Audits attendance
• Assessment of the manufacturer's product changes, their impact on local registration dossiers and planning of required actions to ensure business continuity
• Effective cross-functional interaction on issues related to the registration of medical devices and their further circulation on the market
• 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
• Develop relationships: participation in conferences and seminars organized by state authorities involving in registration process

Requirements:

• Higher education (Biomedical engineering education / background is an advantage)
• 2 + of experience in Regulatory Affairs in Medical Devices preferably
• Knowledge of legislation on registration of medical devices
• Knowledge of English language, sufficient 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