Trainee Product Engineer BME - Freshers

• Good knowledge of USFDA & EMEA guidelines.
• Knowledge of 21 CFR Part 11 for regulatory compliance in alignment with client objectives.
• Knowledge of interpreting the Regulatory requirements
• Knowledge on Medical Device Regulatory Guidelines Literature search on regulatory requirements including labeling information the registration process
• Ability to understand the purpose and requirements of the assigned project and deliver consistently highquality clinical/regulatory documents that meet project requirements.
• Liaising with medical biomedical engineering scientific and clinical staff
• Good time management meeting deadlines and commitments.
• Good Communication skills Listening skills and Problemsolving skills.
• Good knowledge of usage of MS Office applications

biomedical engineering,clinical research,regulatory requirements,clinical services,cfr