Experienced in Regulatory Affairs (Medical Devices) and also in complaint handling reporting and trending in TrackWise tool. Familiarity with 21 CFR 820, 21 CFR 803 and other medical device regulations.Experience of conducting investigations of discrimination complaintsProficient with QMS software like TrackWise, Salesforce, SAP, EDHT.Experience in performing Triage to discriminate between Complaints, Non Complaints, or as Duplicate Complaints.Wide knowledge of FDA regulations safety standards and regulatory compliance guidelines.Analysed complaint data monthly to identify new and systemic issues as necessary.