2 of 2 Remote/Hybrid Risk Management Jobs in Oxfordshire

effective, and secure throughout their entire lifecycle. Working closely with System Engineers and cross-functional teams, you’ll champion product safety during development, maintain risk management files, and drive process improvements that meet regulatory obligations.Responsibilities:Lead and support product risk management activities throughout the product development … lifecycle.Identify potential risks, assess their impact, and ensure appropriate measures are in place to reduce risk to acceptable levels.Review and document risk management activities, providing clear recommendations to support product release decisions.Ensure products and processes meet relevant regulatory and risk management requirements.Work collaboratively with cross ...

/SaMD related regulatory and quality requirements for their approval, marketing and lawful commercialization. The role will lead the implementation of ISO13485 and management of the related Quality Management System, the regulatory strategy across EU (IVDR), UK (UKCA/MHRA) and US (FDA, CLIA, LDT, SaMD) markets … biopharma partners on companion diagnostic (CDx) programmes (in the future). The role will also support the company’s existing information security and privacy management certifications (ISO 27001 and ISO 27701), extending these to cover the company’s handling of personal genomic, clinical and payment data. This ...