5 ISO 13485 Jobs in the South West

5+ years’ industry experience. Desirable: Previously involved in the development of wellness and/or medical devices. Experience coding to MISRA standards. Experience writing ISO 62304-compliant software (class A) under an ISO 13485 quality management system. Good understanding of wireless protocols, particularly Wi-Fi and Bluetooth. more »

reliability, and safety of medical devices throughout the development lifecycle. - Support the development of risk management documentation, in accordance with regulatory requirements such as ISO13485 and FDA guidelines. Qualifications: - Bachelor's degree in Engineering, Computer Science, or related field. Master's degree preferred. - Proven experience in systems engineering within the … medical device industry, including knowledge of regulatory requirements such as ISO 13485 and FDA guidelines. - Strong understanding of systems engineering principles, including requirements analysis, system design, integration, testing, and validation. - Excellent communication skills with the ability to collaborate effectively with cross-functional teams and stakeholders. - Experience with risk more »

Desirable requirements Knowledge of medical device regulations such as 21 CFR 820 (QSR) or the 2017/745 MDR and international standards such as ISO 13485 or other regulated industries. Knowledge of Agile Project Management and/or Scrum Methodology. Both Mechanical and Software Development Projects more »

At least relevant technical experience Experience in nucleic acid assay development Commercial in vitro diagnostic product development experience Knowledge of Quality Management & Regulatory frameworks (ISO 13485, 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, ISO 13485, FDA 21 CFR 820 and cGMP. Previous line management experience. Strong laboratory-based background. Attention to detail and well organized. Please share more »