Brazil Regulatory Lead

Há 6 dias

São Paulo, São Paulo, Brasil beBeeRegulatory Tempo inteiro R$50.000 - R$80.000
Regulatory Affairs Specialist

We are seeking a highly motivated individual to act as the technical lead on behalf of our organization in Brazil. As a key member of our team, you will be responsible for ensuring compliance with national and international regulations.

The Role
  • Assist with registering Randox product line in Brazil and other Latin American countries for regulatory affairs purposes.
  • Act as technical lead on behalf of our company in Brazil to Anvisa.
  • Prepare regulatory documentation, review, and interpret previous documents to ensure compliance with regulations.
  • Compile, submit, and follow up on registration files for marketing authorisations and manage them throughout their life cycle.
  • Create new Product Technical files for compliance with IVD directives.
  • Review and approve product labelling for Randox off-the-shelf products.
  • Translate IFU's, labels, dossiers, and SDS's for compliance with regulations.
  • Complete supplier survey forms.
  • Conduct internal audits.
  • Develop and revise manuals, procedures, and technical instructions.
  • Report recalls or customer notifications to Anvisa.
  • Participate in CBDL meetings and professional association groups.
  • Provide regulatory support to the Regulatory Affairs department at HQ and when required.
Requirements
  • Bachelor's degree or equivalent in Pharmacy.
  • Previous experience as technical lead.
  • Previous experience in preparing product dossiers for Class I, II, and III products.
  • Previous experience in submitting information to Anvisa.
  • Excellent verbal and written communication skills.
  • Excellent organisational skills with attention to detail and ability to prioritise.
  • Ability to act on own initiative or as part of a team.
  • Fully computer literate (MS Office Package).
  • Fluent in English.
  • Desirable: Knowledge of registrations in other countries, Quality Systems, 16/2013 resolution, auditing experience, completing and reporting recalls.

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