Overview
Senior Quality and Regulatory Engineer – Medical Devices – Strand, London, WC2R 2LS
About Us
We are seeking experts in medical device design regulatory processes to join our team and work with project groups to translate novel technologies to the clinic.
We welcome applications from individuals with experience in:
- Software as a Medical Device
- Design Controls
- IEC 60601
- Regulatory Affairs supporting MedTech start-up organisations
- Quality Management Implementation
The post holders will be based in the London Institute for Healthcare Engineering (LIHE) part of the School of Biomedical Engineering and Imaging Sciences, King’s College London.
About The Role
Located within a hospital environment, our mission is to generate tangible clinical and commercial translation through our stimulating collaborations to achieve the unexpected, and advance research, innovation and teaching progress through our shared mission of engineering better health for patients worldwide.
The post holders will support a wide variety of research projects in the School and start-up companies as part of our MedTech Venture Builder and Accelerator programmes in the MedTech and Digital Health Hubs to develop new class I to class III medical devices and healthcare technology.
They will operate within the Medical Engineering Quality Management System (QMS), developed to meet the requirements of ISO 13485 and the development of state-of-the-art medical technology, including surgical robotics, active implants, imaging software and AI.
The post holders will be part of a growing Quality and Regulatory Team and provide guidance to project teams on regulatory strategy and planning, quality system procedures, identifying gaps in project information and processes; recommending solutions, and be responsible for developing and maintaining compliant processes and technical documentation that meet the needs of the different stakeholders within and external to the organisation
This is a full time (35 Hours per week), and you will be offered an a fixed term contract for 2 years.
IMPORTANT: Before applying for this role, please make sure you have the right to work in the country where the role is based. Unless it clearly stipulates within in the job advert above that the hiring company is looking to or able to sponsor applicants it is deemed that the hiring employer will only consider applications from those able to comply with and work in the country where the role is based.
