Sr Regulatory Affairs Specialist
2 weeks ago
ABOUT LINGO
Meet Lingo, a new biosensing technology that provides users a window into their body. Lingo tracks key biomarkers â such as glucose, ketones, and lactate â 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.
A New Category of Consumer Biowearables: Meet Lingo - YouTube
THE OPPORTUNITY
Personalized healthcare is the future. Working on Lingo, you will help build a next-generation technology that enables individuals to make decisions about how to improve energy, lose weight or enhance athletic performance. The Lingo team embodies a start-up culture and mindset with the backing of Abbott, a company with a rich history of healthcare innovation. Join us and grow your career as you help Abbott shape the future of healthcare.
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.
WHAT YOUâLL DO
- 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 required
- Serves 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.
EDUCATION AND EXPERIENCE
- A Bachelorâs Degree, ideally in a scientific or technical discipline
- Prior regulatory affairs experience, ideally within medical devices
- Software experience would be advantageous
- Comfortable in a fast-paced environment with tight deadlines and rapidly evolving and expanding project plans
As youâd expect from a global healthcare company, we offer a fantastic range of benefits including competitive salaries, a superb defined contribution pension scheme, private healthcare, life assurance and a flexible benefits scheme, as well as excellent development opportunities.
Abbott is an Equal Opportunity Employer, committed to employee diversity.
Connect with us at www.abbott.com, on Facebook at www.facebook.com/Abbott and on Twitter @AbbottNews and @AbbottGlobal.
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