3 of 3 ISO 13485 Jobs in Oxfordshire

help monitor budget spend against timelines. Risk & Compliance Awareness: Support the team in ensuring project documentation strictly adheres to global regulatory standards (e.g., FDA, ISO 13485, GMP). Flag early risks or bottlenecks to senior leads. Stakeholder Communication: Maintain action logs, prepare progress updates, and assist with draft ...

contributing to scale-up, design transfer or NPI (New Product Introduction) projects in a medical device environment. Strong understanding of medical device regulations including ISO 13485, EU MDR, and FDA QSR/21 CFR Part 820. Proven experience with process validation methodologies (IQ/OQ/ ...

continuous improvement initiatives. What We Are Looking For Regulated Industry Experience: Experience working within a strictly regulated environment (highly prefer medical devices under ISO 13485/FDA 21 CFR Part 820, though Pharmaceuticals or Aerospace will be considered). Validation Background: Proven track record as a Validation Engineer ...