Regulatory Affairs Specialist For Medical Devices

As a Regulatory Affairs Specialist for Medical Devices (Orthopedic Implants And Instruments), your role will involve: - Preparation of documents for ISO13485, CE Certificate (As Per EU MDR), and USFDA. - Working on Technical Master File. - Creating CERs (Clinical Evaluation Report) as per EU MDR. - Handling Design & Development and Risk Management Files in accordance with EU MDR. - Possessing knowledge about QMS (Quality Management Systems). - Reporting to regulatory authorities. - Conducting internal quality audits. - Having expertise in European CE (MDD & MDR) and USFDA 510K. Skills required for this role include: - Proficient in documentation handling. - Strong written and verbal communication skills. - Good knowledge of computers and MS Office. To qualify for this position, you should have one of the following education qualifications: B Pharm, M Pharm, Bachelor or Master Degree in Bio-Medical Engineering or Science Discipline with training in Medical Devices in Regulatory Affairs. Additionally, a minimum of 3-5 years of experience in the Medical Devices industry is required. The salary for this role ranges from 30,000.00 to 80,000.00 per month, depending on the interview performance. Additionally, benefits such as leave encashment, provident fund, and yearly bonus are included. If you are looking for a challenging opportunity in Regulatory Affairs for Medical Devices, this position could be a perfect fit for you.,