Complaint Management and MDR Specialist

About the role

Genpact is seeking an experienced Complaint Management and MDR Specialist to support medical device vigilance for LATAM markets. The role involves reviewing complaint cases, determining reportability, and preparing required regulatory submissions while ensuring compliance with regional guidelines.

Key responsibilities

• Review and assess complaint records for completeness and required actions.
• Document activities in ETQ and support missed investigations.
• Complete decision trees to determine MDR reportability for US, EMEA, and APAC.
• Prepare and submit Medwatch forms and other vigilance reports.
• Gather and attach supporting documentation to complaint files.
• Ensure records comply with SOPs and regulatory requirements.
• Coordinate with Quality, Regulatory Affairs, and product SMEs to resolve issues.
• Escalate patient safety or regulatory concerns to management.
• Participate in calibration sessions and meet productivity/quality targets.
• Maintain audit‑ready documentation and provide status updates for project metrics.

Required profile

• Hands‑on experience in medical device complaint management, post‑market surveillance, vigilance, regulatory affairs, or quality operations.
• Proven ability to complete reportability decision trees for MDR reporting.
• Strong documentation skills and familiarity with LATAM regulatory guidance and timelines.

Required skills

• ETQ (complaint management system)
• Medwatch form preparation
• MDR reporting and decision‑tree analysis
• Regulatory compliance for medical devices
• Complaint documentation and audit readiness

What we offer

• Opportunity to work in a fast‑moving, tech‑driven environment.
• Collaboration with global teams focused on AI and digital innovation.
• Professional growth within a leading advanced technology services company.