Meet Lingo, a new biosensing technology that provides users a window into their body. Lingo tracks key biomarkers – such as glucose, ketones, and lactate – to help people make better decisions about their health and nutrition. Biowearable technology will digitize, decentralize and democratize healthcare, enabling consumers to take control of their own health.
We are recruiting for an experienced Regulatory professional to joins us as a Sr Regulatory Affairs Specialist (EU), working out of our Lingo location in Central London.
Ability to execute highly complex or specialized projects. Adapts precedent and may make significant departures from traditional approaches to develop solutions.Will support the development of product registration submission, progress reports, supplements, amendments, or periodic experience reports.Responsible for change controls and change impact suggestions.Interacting with Regulatory agencies, industry advocacy groups and independent test labs will be requiredServes as regulatory liaison throughout product lifecycle.Participates in some of the following: product plan development and implementation, regulatory strategy, risk management and design control activities working under ISO13485 principles for both hardware and software development.Serves as regulatory representative to marketing, research teams and regulatory agencies.Advises development and/or marketing teams on manufacturing changes, line extensions, technical labeling, and the interpretations of evolving regulations, standards and guidances related to radio equipment, app development, biocompatibility, sterility, waste disposal etc.
A Bachelor’s Degree, ideally in a scientific or technical disciplinePrior regulatory affairs experience, ideally within medical devicesSoftware experience would be advantageousComfortable in a fast-paced environment with tight deadlines and rapidly evolving and expanding project plans