Regulatory Affairs Specialist
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a hardworking professional with 4 years experience in regulatory affairs for medical devices. Experience of all premarket and post-market requirements covering the UK and EU markets (MDD/MDR/UK MDR).
Medical Device Quality Assurance Lead - Bluetree Medical - 1 yr 2 months
As medical device quality assurance lead I am responsible for the day to day running of the ISO 13485 quality management system and assisting with writing technical files and reviewing relevant regulations and guidance to ensure conformity of the medical devices sold by Bluetree Group.
Medical Device Regulatory Affairs Specialist - Bluetree Medical - 1 yr 10 months
As a medical device regulatory affairs specialist, I am responsible for the writing and maintenance of device technical files (medical devices and PPE), reviewing new and upcoming regulations and guidance and ensuring new and existing products meet applicable regulatory requirements
Quality and Regulatory Manager - Bluetree Medical - 6 months
Responsible for technical file creation and maintenance for all products and all associated regulatory activities pre and post-market. PPRC. Current markets include UK, EU, and Thailand. Responsible for the companies ISO 9001, 13485 and 22716 quality management systems.
BSc Biomedical Science - University of Sheffield
MSc Regulatory Affairs (Medical Devices) - TOPRA (University of Sheffield) - Currently Studying
MSc in Regulatory Affairs for Medical Devices, specifically covering the requirement of the MDR (2017/745). Includes modules in Design,Development, and Certification, Clinical Evaluation, Post-market Surveillance and Vigilance, and Regulatory and related activities throughout the device lifecycle. Facilitated by the University of Hertfordshire. This course does not impact my ability to work full time.
