We are looking for a RA/QA Specialist for an international Start Up located in Barcelona which is focused in providing universal and timely diagnosis for life-saving treatments worldwide (artificial intelligence medical imaging software sector).
The candidate will be a pivotal part of the team, responsible for registration and regulatory approvals of our client's products. Will also be responsible for grants, subsidies and quality control systems. The right candidate will have good analytical and writing skills, be willing to prepare appropriate documentation for different audiences, capable of solving problems in a startup environment, looking to improve health care in the world, and save lives.
Main requirements and principal functions:
· Understand and design regulatory strategy for our client products
· Prepare and maintain regulatory approvals, for CE Mark and FDA 510(k)
· Experience in Quality Control systems (ISO 13485) and FDA QSR (21 CFR 820)
· Ensure compliance with privacy regulations (GDPR & HIPAA)
· Design and execute trials for regulatory approval
· Write and maintain user manuals for our client products
· Experience in the medical device regulatory environment
· Exposure the process of registering Software as a Medical Device (SaMD) would be particularly desirable; however, given the relative infancy of the Digital Health market, will also consider people with wider Medical Device experience
· Prepare and follow-up of grants or government subsidies
· None of the above but a good sense of humor and readiness to learn
· Team: be part of a solid team with an extensive experience, passionate about their work and capable to bring cutting-edge technology to market.
· Flexible work-life balance: Our client is focused in the performance and everybody has different ways to achieve it. They make their best so that all the team feel comfortable in their work environment.
· Progression: early stage company with a multidisciplinary team. They offer the opportunity to all the members of the team to grow together with the company.
· Equal Employment Opportunity: They proudly pursue a diverse workforce and they don’t make any hiring or employment decisions that could be discriminatory in any way.
· Benefits: Fee discount at a leading sports center in front of the sea, at a 15min walk from our offices.