Regulatory Affairs Specialist Ii (ivd/medical Devices)

Thermo Fisher Scientific UK

São Paulo, Brazil
On-site
Product compliance and market access
Regulatory submissions and product registrations
Quality management systems
Thermo Fisher Scientific is seeking a Regulatory Affairs Specialist II in São Paulo, Brazil, to ensure compliance and market access for its diagnostic solutions. The role requires expertise in regulatory affairs, particularly in the IVD/medical device sector, and offers opportunities for professional growth within a mission-driven company focused on improving global health and safety

Job Summary

  • Ensure product compliance and market access for our innovative diagnostic solutions.
  • Work with cross-functional teams to manage regulatory submissions, maintain product registrations, and support quality management systems across global markets.
  • Responsible for sanitary compliance at the municipal and federal levels for legal entities and compliance of companies with professional councils.

Matching Summary

Match Score: 85

Thermo Fisher Scientific is seeking a Regulatory Affairs Specialist II in São Paulo, Brazil, to ensure compliance and market access for its diagnostic solutions. The role requires expertise in regulatory affairs, particularly in the IVD/medical device sector, and offers opportunities for professional growth within a mission-driven company focused on improving global health and safety.

Skills & Requirements

Must-have

  • Product compliance and market access
  • Regulatory submissions and product registrations
  • Quality management systems
  • Sanitary compliance at municipal and federal levels
  • Compliance with professional councils

Nice-to-have

  • Support for logistics, commercial, and marketing
  • Merger/acquisition/closure regulatory impact assessment

Key Requirements

  • Bachelor's Degree plus 2 years of experience
  • Regulatory affairs experience in IVD/medical device industry
  • Strong knowledge of regional regulations (ANVISA)
  • Experience preparing and reviewing technical documentation
  • Intermediate English and basic Spanish required

Work Rights

Not specified

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