Regulatory Affairs Specialist

компания "smith & nephew (смит энд нефью)" smith & nephew is a global advanced medical technology business. we support healthcare professionals in more than 100 countries to improve the quality of life for their patients. we are looking for a regulatory affairs specialist based in moscow, russia. the main purpose of this role is to ensure product registrations and regulatory compliance in russia and cis. your main main responsibilities will be: preparing dossiers and submitting registration applications in accordance with the local registration procedure registering new products in accordance with the plan ensuring market continuity of registered products through efficient maintenance and renewal of regulatory licenses accomplishment of post-market activities to ensure regulatory compliance ensuring compliance with current and new regulations and guidelines within russia, belarus, kazakhstan and other cis countries. ensuring compliance with quality and regulatory requirements defined by s&n policies & procedures participating in the cross-functional team activities to participate in projects and achieve objectives support company in identifying and eliminating regulatory risks. requirements: experience in medical device regulations in russia for 3-5 years; updated and comprehensive knowledge of local regulations, and ability to translate them into actionable strategies; fluent english; strategic thinking, organizing and planning; effective negotiation and influencing; resilient, clear thinking, and able to make decisions and recommendations; strong regulatory strategy planning and execution capabilities; clear and actionable communication; accurate sense of urgency, prioritization and delegation; knowledge of iso 9001 and or iso 13485 as a plus. we offer an interesting and varied function in an international and interdisciplinary environment; the opportunity to play a relevant part in a medical network and to further develop a company with an excellent reputation; competitive compensation package and social benefits maternity leave position (employment through our partner)