Regulatory Affairs Executive

Job description We are Hiring QA/Regulatory Affairs Specialist for Medical Devices (Orthopedic Implants and Instruments) Role & Responsibilities: 1. Documents preparation for ISO13485, CE Certificate (As per EU MDR). 2. Work on technical master file. 3. Work on CERs (clinical evaluation report) as per EU MDR. 4. Have knowledge about QMS (quality management systems). 5. Reporting to regulatory authorities. 6. Conducting internal quality audits. 7. Responsibilities for initiating & closing product recall Process. 8. Have experience or knowledge of European CE (MDD & MDR). 9.Have knowledge of USFDA 510K. Skill: 1. Documentation handling 2. Written & verbal Communicate skill 3. Have good knowledge of computer and MS Office. Education Qualification of candidate: B Pharm / M Pharm / Bachelor or Master Degree in Bio-Medical Engineering / Science discipline with training in medical devices in Regulatory Affairs