Regulatory Affairs Specialist

4 semanas atrás

São Paulo SP, Brasil Mindray Tempo inteiro

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.

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