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Title

Biomedical Engineer

Description

We are looking for a Biomedical Engineer who will work together with the head of the company's Regulatory Affairs & QA department.

This is an excellent opportunity for an experienced professional to put their talent, skills and experience to work in a young, high potential startup dedicated to improving people's lives.

The candidate will have a high degree of freedom to put their talents into practice while learning from experienced colleagues and joining a team currently composed of more than 15 people and with a strong network of external collaborations.

Requirements
  • University education in engineering (preferably biomedical engineering) or health sciences.
  • Proactive, organised and methodical profile.
  •  English: fluent conversation (B2 level).
  •  Internship experience in the area of Quality and Regulatory Affairs (ideally with the medical device sector) in one of the following areas will be a plus:
    •  European regulations on medical devices (EU 2017/745), ISO 13485 quality management systems, or standards: ISO 14971, ISO 14155, MEDDEV and FDA guidelines.
  • Identify, design and implement the company's processes in terms of product quality, safety and efficiency.
  • Verify that the technical documentation and the EU and American declaration of conformity are drafted and updated.
  • Manage reporting obligations and ensure compliance of medical devices with the quality management system in the manufacturing process.
  • Strengthen and intensify relationships with clinical teams in order to improve processes.
  • Detect system risks that affect internally or external collaborators.
  • Constant dialogue with suppliers, regulatory authorities (Spanish and international), medical staff.
What we offer?
  • Joining a cutting-edge technology startup offering disruptive medical solutions.
  • Professional development opportunities
  • Interesting financial conditions

If you have any doubt related to this position, please send us an email to info@denebmedical.com