- 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.
- Assessment 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 legislation
- Interface 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.)
- Degree in Biomedical or Farmacy
- Excel
- Advanced English
- Local laws – RDC , Anvisa procedures
- Previous experience in medical devices companies – or pharmaceutical
- At least 5 years of experience working as Regulatory Affairs Analyst/ Specialist or similar roles.
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Regulatory Affairs Specialist - Greater São Paulo Area, Brasil - Mindray
Descrição
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:
Main activities
Requirements
Mindray Brazil offers an exciting professional environment. Only those who meet our requirements will be contacted. Mindray is an equal opportunity employer.