Perform preliminary complaint intake, management, and event classification.
Conduct customer follow-ups and assess complaints for regulatory reportabilityin accordance withFDA 21 CFR 803, EU MDR 2017/745, and ISO 13485.
Prepare and submit MDR, MIR, vigilance, and global adverse event reports, achieving zero late submissions.
Collaborate closely with stakeholders and team members, providing guidance and coaching to drive engagement and performance.
Demonstrate strong knowledge of Post-Market Surveillance requirements (US FDA and EU MDR), Quality Management Systems (ISO 13485, 21 CFR 820), and complaint handling tools such asTrackWiseor equivalent systems.
Experience withTrackWiseand Microsoft Project ; Post Market Surveillance as per US FDA & EU MDR ; Quality Management (ISO 13485 or 21 CFR 820 ; working with multiple teams and collaborating across geographically spread multi-functional teams.
Understanding on Medical Device Risk Management
What you will need-
Required-
BE/BTech/ME/MTech in Bio Medical / Mechanical Engineering / Electrical Engineering or related field from premier institutes
Experience- 2years to 5 years
1-2years of experience in Medical Device domain; At least1+ years of experience in complaint handling or customer quality.
Preferred-
ISO 13485:2016certification
Strong analytical and problem-solving skills; excellent written and verbal communication skills and proficiencyin QMS software and tools.
Able toruncommunicate effectivelywith senior leadership.
Excellentproblem-solvingskills.
Proactive to support both internal and externalcustomers.