Regulatory Affairs Specialist (Медицинское оборудование)

компания "johnson & johnson" johnson & johnson (medtech division) is looking for a strong candidate for regulatory affairs specialist role 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 maintain and updаtеrd database: enter new documents to db and notification of all concerned parties (upon appropriate mailing list) certificates tracking and updаtеin 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 english language, sufficient for business communication purposes 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