1 to 2 of 2 Permanent ISO 13485 Jobs in Oxford

the ability to implement robust document control processes while working closely with the Head of Quality and Regulatory Affairs establish the QMS aligned with ISO 13485 requirements, driving continuous improvement and operation excellence. The successful candidate will also compile technical files with comprehensive documentation to support regulatory submission … and product certification while conducting risk management activities in accordance with ISO 14971, identifying potential hazards, assessing risks and implementing effective mitigation strategies. Quality and Regulatory Specialist Key Responsibilities: Manage and organize quality and regulatory documentation Ensure timely and accurate filing per industry standards Maintain compliance with regulatory requirements … regulatory affairs within the medical device industry, preferably with exposure to software (IEC 62304) and Software as a Medical Device (SaMD) Strong understanding of ISO 13485, ISO 14971, and other relevant regulatory standards Excellent communication skills with the ability to collaborate effectively across multidisciplinary teams Detail-oriented more »

in circuit design, schematic capture, PCB layout, and simulation tools. Experience of version control systems (Altium, PDM etc) Familiarity with regulatory standards such as ISO 13485 and IEC 60601 is a bonus but not a deal-breaker. Excellent problem-solving skills and attention to detail. Ability to thrive more »