Senior Regulatory Affairs Specialist

How would like to spend your workday looking out over the Mediterranean? Then this role for a Senior Regulatory Affairs / QA Specialist at Tech City in Barcelona could be just what you are looking for.

The successful candidate will be implementing the regulatory and quality activities within the company to ensure compliance with standards and regulations for medical devices. Applying extensive organizational skills and knowledge both as an individual and as part of a team, you will assure that documents meet the needs of the organization as well as meeting regulatory and quality assurance requirements.

The RA/QA Senior Specialist is expected to provide significant guidance as well as hands on support in the development of new documents, procedures, processes and other quality system documentation.

Duties and responsibilities

• Manage and maintain compliance with the EU market Medical Device Regulation (MDR2017/745)
  
• Create and update the Technical Documentation and EU Declaration of Conformity
  
• Create and update the 510(k) Submissions for the FDA
  
• Create and submit pre-submission documentation for the FDA
  
• Update of post-market surveillance and post-market clinical follow-up activities alongside vigilance reporting obligations
  
• Responsible for the conformity of the product and Quality Management System (QMS)
  
• Actively participate in the maintenance and continuous improvement of the Quality System
  
• Implement and maintain Data Protection activities with the support of the Data Protection Officer (DPO)
  

Requirements

• Extensive 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
  
• Understanding of medical device regulations and standards
  
• Basic knowledge of GDPR and HIPAA requirements
  
• Great communication, presentation and interpersonal skills
  
• Fluent in English
  
• Strong teamworking skills with a strong drive to succeed
  

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.