Remote LATAM Regulatory & Quality Specialist

Jobgether SRL; United States; Remote; USD 18,000 - 28,000; Full time

Benefits offered by this job

Remote work within Brazil

Full-time position

International collaboration

Professional development

Job summary

Jobgether SRL is seeking a Regulatory Affairs and Quality Assurance professional to support regulatory documentation, risk revalidations, and quality processes across Latin America.

You will maintain the Brazil Regulatory Management Plan, track CAPAs and non-conformities, assist with distributor and service provider qualification, ensure GDP/GSP compliance at 3PL sites, and help uphold ANVISA and regional QMS standards.

Qualifications

• Understanding of regulatory documentation and quality management systems.
• Familiarity with ANVISA requirements and GDP/GSP.
• Ability to prepare, maintain, review, and track regulatory files and quality records.
• Experience with non-conformity management, CAPA monitoring, and audits.
• Experience supporting distributor and service provider qualification/requalification.
• Ability to maintain structured records and use tracking tools like Smartsheet.
• Attention to detail and analytical thinking in documentation and processes.
• Strong communication and teamwork across regional operations.

Responsibilities

• Prepare regulatory documentation and risk revalidations for Risk Classes I–IV as requested by the manager.
• Maintain the Brazil Regulatory Management Plan (RMP) and regulatory files.
• Update and maintain Smartsheet records following management instructions and workflows.
• Support GDP/GSP compliance at 3PL facilities with Responsible and Co-Responsible Technicians.
• Open, document, and follow up on non-conformities with clear tracking and communication.
• Coordinate CAPAs with relevant departments and ensure timely follow-up.
• Draft and maintain Regulatory Affairs and GDP/GSP procedures within the regional QMS.
• Follow approved procedures and seek guidance when clarification is needed.
• Assist with distributor qualification and audits, and service provider reassessment.
• Coordinate field actions and technical vigilance documentation with technicians.

Skills

Regulatory affairs knowledge

Quality management systems

Documentation and records management

CAPA monitoring

Audit support

Distributors qualification

Attention to detail

Cross-functional teamwork

Tools

Smartsheet

Job description

Jobgether SRL is seeking a Regulatory Affairs and Quality Assurance professional to support regulatory documentation, risk revalidations, and quality processes across Latin America.

You will maintain the Brazil Regulatory Management Plan, track CAPAs and non-conformities, assist with distributor and service provider qualification, ensure GDP/GSP compliance at 3PL sites, and help uphold ANVISA and regional QMS standards.