A dynamic Digital Health start-up based at Barcelona s premier Mediterranean waterfront tech-hub seeks a Regulatory Affairs / Quality Assurance Specialist.
The successful candidate will support the regulatory and quality activities within the company to ensure compliance with standards and regulations for medical devices. Working under the supervision of the RA/QA Director the ideal candidate is will previous experience in the field of RA/QA and most importantly is highly motivated to undertake a role in the AI medical imaging space.
Duties and responsibilities
- Write/review policies/procedures and related documents for the development of Software as a Medical Device in compliance with applicable standards and regulations
- Support in the creation of documents related to regulatory submission documentation in both EU and US markets
- Perform QA activities related to Software as a Medical Device (SaMD) Development.
- Ensure compliance with software development lifecycle requirements, policies, and procedures
- Actively lead and participate in the development resolving quality issues
- Support in the implementation and maintenance of Data Protection activities
Requirements
- Previous experience in RA/QA
- Bachelor s degree or equivalent in science/engineering/technical discipline
- Strong motivation to develop a career in RA/QA in AI medical imaging
- Experience in Medical devices, ideally in the development of software
- Great communication, presentation and interpersonal skills.
- Fluent in English
- Strong teamworking skills within a proactive and innovative environment
Benefits
This is an amazing opportunity to join an elite start-up, to work on an impactful healthcare project. You have the chance to parachute into one of Europe s most dynamic entrepreneurial digital health ecosystems and enjoy the best quality of life that Europe has to offer.
You will be working for a talented, focused, and visionary team of leaders who put employee satisfaction, professional development and a fun, motivating workplace at the top of their agenda. You will have world-class access to experts in the field of SaMD quality assurance to learn from.
Your workplace is 5 minutes walk from the iconic Barceloneta beach in one direction and the historic centre of old Barcelona in the other. This fast-growing company offers growth opportunities in line with their ambitious expansion plans.