Barathkumar Manoharan, Rcc-Mdr, Msra Email & Phone Number

Toronto, ON, CA

Cambridge, Ontario, Canada

• Assisted in regulatory submissions to Health Canada and managed MDL applications, annual licensing renewals, Faxback forms, and licenses amendment for Class II and III medical devices.
• Performed design change assessments, incoming QA inspections, reviewing technical files, labels, and marketing materials for aesthetic, surgical, and vision product divisions.
• Managed QMS activities for change control, recalls, PMS, and complaint handling, in a fast-paced environment achieving a 90%… Show more
• Managed QMS activities for change control, recalls, PMS, and complaint handling, in a fast-paced environment achieving a 90% compliance rate during audits through effective eQMS management.
• Conducted internal audit for 2024, identifying and addressing three non-conformances and implemented corrective actions to enhance operational efficiency.
• Drafted and updated quality system documents, including SOPs, work instructions, forms, templates, to ensure consistent regulatory compliance across product divisions. Show less

United Kingdom

• Developed regulatory strategies for AI & ML-based SaMD Inhaler for the successful market entry in Canada.
• Designed a preclinical trial design to assess safety, performance, and feasibility of the smart inhaler.
• Prepared a clinical trial plan outlining phases, participant selection, informed consent procedures, data collection methods, and safety monitoring protocols.
• Compiled findings and trial designs in a report for regulatory submission, presented key takeaways and future… Show more Developed regulatory strategies for AI & ML-based SaMD Inhaler for the successful market entry in.
• Compiled findings and trial designs in a report for regulatory submission, presented key takeaways and future considerations. Show less

Chennai, Tamil Nadu, India

Successfully transitioned MDD to MDR compliance, providing detailed guidance, reducing potential fines.Compiled technical files and GSPR per EU requirements.Assisted in regulatory impact assessments and file amendments for post-market changes.Identified and resolved discrepancies in product design, labels, and IFUs to ensure regulatory compliance.

Bengaluru Area, India

Conducted gap analysis on Class III devices for EU MDR, US FDA, and ISO compliance.Managed regulatory approvals for CRM products, including 510(k) and CE marking.Streamlined document process for DMF, DHR, and QMS using PLM tools, publishing IFUs and labels.Collaborated with marketing, SMEs, and R&D, gather product information and address regulatory.

Bengaluru, Karnataka, India

Chennai, Tamil Nadu, India

Master'S Degree, Regulatory Affairs, 3.7

Be - Bachelor Of Engineering, Biomedical/Medical Engineering, 3.2