As a Junior Regulatory Affairs and/or Quality Affairs Consultant you work closely with our Head of Regulatory to support medical device (MD), in-vitro diagnostic medical devices (IVD) with a focus on software as medical device (SaMD), including AI as a medical device (AIaMD), companies to bring their products to market, by achieving CE Mark in EU and/or similar approval in other countries.
We are looking for people that may not know much about the field, but are eager learners, and seek all sorts of information to have the best opinion on strategic decisions.
If you believe that making a product clear to everyone, writing detailed documentation about it, keeping track of all the small details in an engineering project, imagining how to make an architecture of software compliant and spending some time discussing some legal wording interpretation would make your day, then this job is for you.
You will support the implementation of Medical Device Regulation (MDR), In-Vitro Medical Device Regulation (IVDR), FDA (US) and corresponding standards, such as ISO 13485 (Quality Management System), ISO 27001 (Information Security), among others. You will have access to top training in this field, but you will only succeed if you are a proactive and efficient learner, since this is a field you never know enough.
You will work with the most innovative companies and startups across Europe in the field of Digital Health, getting to understand their product, business and processes, to support their endeavours of navigating the Medical Device and In-Vitro Medical Device Regulations across the world.
You will continuously learn by doing, working hands-on in projects, with access to the best expertise in the field and with the support of our team of experts you will be exploring novel approaches and become yourself an expert in the field. At the same time, you will have a unique opportunity to contribute to the launch of a new Digital Product that will change how companies navigate the regulatory requirements of medical devices.
Complear is based in Portugal, but we work fully remote, so you can live anywhere in the world.
THE ABSOLUTE UNICORN CANDIDATE
This is a great position for someone who wants to gain experience in regulatory affairs of medical devices focused on Digital Health, and not be afraid of exploring new approaches to traditional consultancy.
We are looking for someone with:
- A Graduate degree in a relevant educational engineering field (e.g. Biomedical Engineering, Engineering or similar subjects)
- Good communication skills, quick learner and computer savvy
- English Language Proficiency (Portuguese is desirable but not required)
- Initial knowledge of EU and/or FDA medical device regulations
- Familiar with the concepts of Medical Device Regulation, ISO 13485 and FDA QSR and IEC 62304 requirements within a Quality Management System, would be a plus
- Experience in the preparation of Technical Documentation for Medical Devices, in particular, Medical Device Software, would be a plus
- Communicative team player, able to work in a precise and goal-oriented manner with the capability of independent and networked thinking
- Feel comfortable not reinventing the wheel as long it delivers something more efficiently
- An ability to keep things organised, prioritise, and be responsible for setting and meeting deadlines in a remote team
We often seek people with diverse profiles ready to jump into new projects, exposing them to new challenges, significantly beyond the traditional university curriculum, or day-to-day job.