Regulatory Affairs Analyst
On-site · Sao Paulo, São Paulo, Federative Republic of Brazil
Job Summary
Regulatory Affairs Analyst responsible for coordinating and preparing document packages for regulatory submissions, license renewals, and annual registrations; lead materials for submissions and audits; recommend changes to labeling, manufacturing, marketing, and clinical protocols for regulatory compliance; monitor tracking systems; may direct interaction with regulatory agencies; requirement of a Bachelor’s degree in a related field, 2–3 years regulatory affairs experience in medical devices in Brazil, and advanced English; experience with Anvisa and Inmetro, health registrations, audits/CAPA is a plus, and familiarity with GMP, GDP, and ISO 13485. Must be based in São Paulo, Brazil, with an in-office/hybrid arrangement noted as not available for transportation + hybrid options.
Required Qualifications
- Bachelor’s degree in Pharmaceutical Chemistry, Biomedical Engineering, Medicine, Chemical Engineering
- Two to three years of regulatory affairs experience in medical device companies
- Advanced English proficiency
- Experience with regulatory submissions and interactions with agencies such as Anvisa and Inmetro
- Experience preparing/validating, renewing, and modifying health registrations
- Experience with internal and external audits / CAPA (advantageous)
- Knowledge of GMP, GDP, ISO 13485 (advantageous)
- Experience with labeling changes and regulatory compliance
- Ability to monitor/regulate regulatory procedures and changes
- Ability to direct interaction with regulatory agencies on defined matters
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