Regulatory Affairs Specialist

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 activities

• 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.)

Requirements

• 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.

Mindray Brazil offers an exciting professional environment. Only those who meet our requirements will be contacted. Mindray is an equal opportunity employer.