* Good knowledge and understanding of EU Regulatory guidelines(MDD/93/432/EEC) for Submissions of Medical Devices*Responsible for clinical evaluation regulatory documentation of class III, Class II and class I medical devices submission as per Meddev 2.7/1 Rev.4 including PMS and PMCF*Good knowledge of EN ISO 10993-1:2009 for evaluation of medical devices*preparation of standard operating procedures (SOPs) and quality system procedures (QSPs) as per relevant standards and guidelines.*involved in delivering training for clinical evaluation of medical devices as per Meddev 2.7/1 Rev. 4.*working experience with domestic as well as international clients for the clinical evaluation of medicine devices as per EU guidelines