At least relevant technical experience Experience in nucleic acid assay development Commercial in vitro diagnostic product development experience Knowledge of Quality Management & Regulatory frameworks (ISO13485, FDA 21 CFR 820, cGMP) Previous line management experience If you're ready to make a substantial impact in the realm of more »
a relevant scientific discipline. Significant (>3 years) relevant technical experience. Nucleic acid assay development experience. Commercial IVD product development experience. Quality Management & Regulatory frameworks, ISO13485, FDA 21 CFR 820 and cGMP. Previous line management experience. Strong laboratory-based background. Attention to detail and well organized. Please share more »
Looking For: * Minimum 3 years of experience in regulatory affairs within the diagnostics industry. * Strong knowledge of IVD device regulations, including 21CFR, IVDR, and ISO 13485. * Excellent communication, writing, and problem-solving skills. * Ability to work effectively in multidisciplinary teams and make informed decisions. * Understanding of when to escalate more »
the LEX Diagnostics team. What you will be doing: Manage the Quality and Regulatory documentation workflows for the LEX Product portfolio and adhere to ISO13485 requirements. Coordinate and facilitate documentation reviews and approvals involving the relevant people Assess the progress and effectiveness of the documentation control system, addressing any errors more »
Hereford, Herefordshire, West Midlands, United Kingdom
Hunter Selection
robotics are used wherever possible, designing and implementing 6-axis cells and introduction electronic and logic controls to automate where possible. Comply with all ISO13485 requirements. Knowledge, Skills & Experience: An experienced Injection Moulding Technician, with experience of manufacturing products to tight tolerances, using high grade polymers. Demonstrable more »
Engineer, Berkshire: - Experienced in mechanical and electrical testing - Experience in both hands-on testing and documentation writing - Experience in highly regulated industries - Experience of ISO13485 is highly desirable For more information or to apply for the Contract Verification Engineer opportunity based in Berkshire, please contact Jack Kelly -/ more »
refrigeration specifications are feasible to source by connecting to suppliers and manufacturing operations Provide specific documentation related to product design to meet regulatory compliance: ISO 9001, 13485 and organization requirements Assist on quality complains from the field by providing technical support to identify root cause, short- and long … and heat transfer Design Engineer will have experience working in formalized phase-gate product development process, using Design tools such as DFM, FMEA and ISO 9001 design controls Experience on SolidWorks (CAD) If you would like to find out more about this Design Engineer opportunity, click the "APPLY NOW more »
laboratory sector. The products are supported with a full range of laboratory services as well as comprehensive servicing and repair capability. The company is ISO13485 certified. We have an excellent opportunity in our Services Team for a Service engineer who is looking to build on their experience to date working … the ability to respond to emergencies. Experience of maintenance repairs, such as electrical, and plumbing. To have an understanding of Quality Standards such as ISO13485, ISO9001, ISO14001 or other applicable standards, working with a Quality Management System. Ability to work independently and manage time effectively. Maintain accurate records of maintenance more »
