Lead App Developer - Software as Medical Device (SaMD)

For our Medical Device Company we are recruiting for an expert in App Development to support their expanding development of "Software as a Medical Device" (SaMD) You will be a recognized expert for the development and maintenance of safety critical mobile and/or web applications and will take over the technical leadership for the software development part for projects classified as SaMD within the PackagingExcellent understanding of software design and programming principles as well as in overall verification strategies, including test set up and test automation
- Considerable experience of managing external suppliers
- General understanding of Human Factors Engineering, risk management and clinical studies processes and requirements Understanding of medical device regulations (FDA 21CFR 820, FDA 21CFR Part 4, EU Medical Device Directive, EU Medical Device Regulation), including those related to medical software (IEC 62304)
-Development and writing of technical documentation of drug/device combination products and medical devices, including the design control process and other applicable regulatory, QA and GMP aspects
- In addition to outstanding project management and interpersonal skills, a strong background in software development and life cycle management, as well as the use and implementation of platform technologies, is crucial for this role. The successful candidate will play a critical role in the support and sustainable expansion of the SaMD area.

Michael Bailey International is acting as an Employment Business in relation to this vacancy.