Regulatory Affairs Specialist

Position: Regulatory Affairs Specialist Qualifications Preferable: Bachelor’s or Master’s degree in Biomedical Engineering Desirable: Master’s degree in Pharmacy, Medical Devices, or Science Experience Preferable: 4 to 5 years of experience in Regulatory Affairs and Quality Assurance in cardiac implantable devices Desirable: 4 to 5 years of experience in Regulatory Affairs and Quality Assurance in Class IIb and Class III implantable devices Job Description Determining the appropriate risk class for a given device, including assessing the potential risks associated with its use, is crucial. This involves evaluating the device’s performance, safety, and efficacy, as well as considering any relevant regulatory requirements or guidelines.