Regulatory affairs and quality technician

Job Description:

At Laboratorios Rubió they continue to bet on new talent to help them continue to grow as professionals within the medical-pharmaceutical sector.

Its diagnostic business unit continues to grow and for this it is essential to collaborate with RUBIÓ METABOLOMICS, a biotechnology company of the Rubió group, leader in the development of products for early diagnosis of diseases and R&D services for the scientific community and industry in the sectors of human and animal health, food, nutrition, cosmetics, among others.

They currently have a vacancy for a regulatory affairs and quality technician for the laboratory in Derio, in the Basque Country.

They are looking for a proactive and resolute person eager to learn and face new challenges.

 

Candidate profile:

• Knowledge of ISO 9001:2015 and 13485:2016 quality management systems.
• Advanced English level.
• Knowledge in ISO 15189 and good laboratory practices.
• Knowledge of EU regulation 2017/746 on in vitro diagnostic medical devices.
• Previous experience in Quality and Regulatory Affairs position for medical device.

 

Functions:

• Work on compliance with regulations set by EU and FDA for marketing authorization of in vitro diagnostic products.
• Registration and maintenance of technical dossiers for in vitro diagnostic medical devices in the different jurisdictions.
• Communication with notified bodies and health authorities.
• Maintain the quality system, procedures and registrations in the different areas of ISO 9001 and 134585 standards, as well as the new EU regulation 2017/746.
  Lead the development of technical dossiers for in vitro diagnostic medical devices, together with the technical manager and with the collaboration of the technical staff.
• Participate in both internal audits, as well as external audits with the notified body and with customers.
• Identification and control of legal and regulatory requirements in collaboration with other areas.
• Management of non-conformities, corrective and preventive actions, in collaboration with all areas of the company.
• Internal staff training on quality and regulatory issues.

 

They offer:

• Stable hiring.
• Full time.
• Possibilities for professional growth and development.
• Work in a multidisciplinary team and in a company with a lot of projection.

 

If you are interested you can register to the offer in the LinkedIN post.

OWL is a leading biotechnology company in the development of products for early diagnosis of diseases and R&D services for the scientific community and industry in the sectors of human and animal health, food, nutrition, cosmetics and others.

If you are curious to be part of this project that is in continuous growth, do not hesitate to send them your application so that they can contact you.