Senior Complaints Analyst (Medical Device) | BPO

We are looking for a detail-oriented Senior Complaints Analyst to manage and evaluate medical device product complaints, ensuring compliance with regulatory standards and delivering accurate technical documentation.

Key Responsibilities:

• Review, assess, and document medical device product complaints in accordance with company and regulatory requirements
• Prepare clear, accurate, and comprehensive medical and technical narratives
• Ensure compliance with ISO 13485 and other applicable ISO/GxP standards
• Analyze complaint data and identify trends or quality issues
• Collaborate with cross-functional teams to resolve product concerns
• Maintain accurate and timely complaint records in the system

Qualifications:

• Bachelor’s degree in Nursing, Biology/Microbiology, Biomedical Engineering, Industrial/Mechanical Engineering, or related field
• At least 3 years of experience in medical device product complaints management
• Strong knowledge of complaints handling within the medical device industry
• Familiarity with ISO 13485 or other ISO/GxP standards is preferred
• Excellent written and verbal communication skills

Benefits & Perks:

• Competitive salary package
• Night shift differential
• Hybrid work setup (onsite during probation, work-from-home after)
• Weekends off (fixed schedule)
• HMO coverage + dependent