RA Specialist, Latin America

Há 4 dias


Barueri, Brasil Intuitive Surgical Tempo inteiro
Job Description

Primary Function of Position

The RA Specialist oversees Latin America Countries, supporting distributors in this region by evaluating medical device/facility registration and changes notifications, to determine and execute registration strategy and ensuring compliance of marketing material

Essential Job Duties

This position has responsibility and authority for:

  • Elaborating Product Registration Dossier for hybrid countries, like Brazil and Mexico
  • Preparing submission documentation with the assistance of the distributor, where required
  • Answering Additional Inquiries from the Ministries of Health or any other entity involved on product registration or other licenses/certificates
  • Managing registration processes with consultants, when necessary
  • Controlling Licenses Renewals
  • Assessing Global Regulatory Assessments (GRAs/MRPs) related to product, facility and/or process changes
  • Managing assessments related to the GRA/MRP and submission processes in Agile, Product Registration database (PRdb) and BOX drive locations
  • Requesting translation for product registration and other certification provided by the countries that are not in English
  • Update trackers in order to keep the processes information updated
  • Managing communications with in country health authority
  • Reviewing periodically the regulatory requirements by region / country (Regulatory Surveillance Process)
  • Updating internal Work Instructions according changes in the countries requirements
  • Communicating submission status with commercial and marketing teams
  • Assisting and supporting other employees, teams and field personnel as necessary
  • Supporting INMETRO and ANATEL certification
  • Participating on Association meetings
  • Participating on trainings (QMS, technical and product)
  • Managing specific projects for process improvements
  • Other regulatory tasks and projects may be assigned as necessary


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