Quality Systems Analyst
On-site · Sao Paulo, São Paulo, Federative Republic of Brazil
Job Summary
Quality Systems Analyst focused on Brazil Post Market Vigilance to support MDR-related reportability decisions and PMV processes across LATAM. Responsibilities include ensuring timely Medical Device Reports to ANVISA, maintaining PMV process stability and efficiency, improving vigilance timeliness, executing and closing PMV activities, and developing quality metrics and monthly reports. Must ensure compliance with quality standards (ISO 13485) and support the Brazil local QARA with defined SLAs. Role requires collaboration across regions, a strong regulatory reporting background, and proficiency in English; office presence in São Paulo is required.
Required Qualifications
- Bachelor's or higher degree in Medical, Biological Science, Pharmaceutical Science, Engineering, or related discipline
- 2-3 years of experience in Post Market Surveillance, Vigilance or QA/RA
- Advanced English (speaking, reading, writing)
- Good computer literacy (MS Office)
- Knowledge of GDP
- Knowledge of ISO 13485 and its implementation
- Experience/regulatory knowledge for adverse event reporting for medical devices is advantageous
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