Regulatory Affairs Analyst
On-site · Sao Paulo, São Paulo, Federative Republic of Brazil
Job Summary
Regulatory Affairs Analyst at Medtronic Brazil responsible for coordinating and preparing document packages for regulatory submissions, leading materials for license renewals and registrations, and advising on labeling, manufacturing, marketing, and clinical protocol changes to ensure regulatory compliance. The role requires collaboration with regulatory agencies, monitoring tracking systems, and staying up-to-date with regulatory procedures. Requires a Bachelor’s degree in relevant fields, 2-3 years of regulatory affairs experience in medical devices in Brazil, advanced English, andExperience with Anvisa/Inmetro; audits/CAPA experience and familiarity with GMP, GDP, ISO 13485. Employment offers a flexible working arrangement with presence in the São Paulo office; hybrid/remote options are not available for clinical and sales areas, per the posting."
Required Qualifications
- Bachelor’s degree in Pharmaceutical Chemistry, Biomedical Engineering, Medicine, or Chemical Engineering
- Two to three years of relevant experience in Regulatory Affairs within medical device companies in Brasil
- Advanced English proficiency
- Experience preparing/validating, renewing, and modifying Health Registrations
- Experience with government agencies such as Anvisa and Inmetro
- Experience with internal and external audits / CAPA (Corrective and Preventive Actions) is a plus, as well as experience with Good Practice Certifications (GMP, GDP) and ISO 13485
Apply with one swipe on Sorce. We auto-fill applications and apply on your behalf — no cover letters, no 40-minute forms.
Hiring someone like this?
Get your role in front of qualified candidates on Sorce.