Regulatory Affairs Specialist Ii (ivd/medical Devices)

PPD (Thermo Fisher)

Bachelor's degree plus 2 years experience
Strong knowledge of anvisa regional regulations
Experience preparing regulatory submissions
This role ensures product compliance and market access for innovative diagnostic solutions within the Thermo Fisher Scientific team

Job Summary

  • This role ensures product compliance and market access for innovative diagnostic solutions within the Thermo Fisher Scientific team.
  • The specialist will manage regulatory submissions, maintain product registrations, and support quality management systems across global markets.
  • Responsibilities include evaluating merger/acquisition processes by assessing regulatory impact and ensuring health regulations are met locally.

Matching Summary

This role ensures product compliance and market access for innovative diagnostic solutions within the Thermo Fisher Scientific team.

Skills & Requirements

Must-have

  • Bachelor's Degree plus 2 years experience
  • Strong knowledge of ANVISA regional regulations
  • Experience preparing regulatory submissions
  • Intermediate English and basic Spanish required

Nice-to-have

  • ANATEL regulatory knowledge desirable
  • Life Sciences or Pharmacy field of study
  • Excellent organizational and communication skills
  • Detail-oriented with strong documentation skills

Key Requirements

  • Bachelor's Degree in Life Sciences, Pharmacy, Biology or related field
  • Minimum 2 years of Regulatory Affairs experience in IVD/medical devices
  • Proficiency in Intermediate English and basic Spanish languages

Work Rights

Not specified

Tailored Resume

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