Regulatory Affairs / QA Specialist

A dynamic Digital Health start-up based at Barcelona s premier Mediterranean waterfront tech-hub seeks a Regulatory Affairs / Quality Assurance Specialist.

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.