Be part of Mindray Brazil as Regulatory Affairs Specialist!!Mindray is a Chinese multinational manufacturer of medical instruments with headquartered in Shenzhen, Guangdong. The company designs and produces medical equipment and accessories, with presence in more than 190 countries and regions, with a strong commitment with research and development. Our mission is focus on Advance medical technologies to make healthcare more accessible.With Mindray as Regulatory Affairs Specialist, your main responsabilities will be:Support manager in daily activities related to Regulatory Compliance such as: Maintaining the company's legal documentation – contracts governaments reports Follow up expire registration in estances like ANVISA, INMETRO and other regulatory bodies, so that the products can be sold in the national territory.Main activitiesAssessment of current technical documentation and its updates for preparing dossies for:Registration, post-registration and registration renewal and submite in relater webiste and follow up the process; Follow up update laws and requisitions which can impact in current or future product registration; Meeting all the specific requirements of each product line, if any, to understand the strategy to register product; Support in regulatory routine activities: database updating, translations, manuals updates, local payments in Concur and area reports; Assessment of applicable legislation published by health bodies, interpretation and reporting to management in China with preparation of an adaptation plan, when necessary Support for questioning internal (tenders/imports) and external customers regarding the applicability of local legislationInterface with Quality department providing documents/informations for external audits; Effective participation in meetings promoted by health supervisory bodies and professional associations (ABIMED, CBDL, ABIMO, etc.)RequirementsDegree in Biomedical or Farmacy ExcelAdvanced EnglishLocal laws – RDC, Anvisa procedures Previous experience in medical devices companies – or pharmaceuticalAt least 5 years of experience working as Regulatory Affairs Analyst/ Specialist or similar roles. Mindray Brazil offers an exciting professional environment. Only those who meet our requirements will be contacted. Mindray is an equal opportunity employer.
