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.
- 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 firstname.lastname@example.org