Clinical Analysis Specialist

They currently have a vacancy for a Clinical Analysis Specialist for the laboratory in Derio, in the Basque Country. They are looking for a proactive and resolute person who is eager to learn and face new challenges.

Job description:

• Acting as the person responsible for care before the competent authority
• Working in compliance with the regulations established by the EU and the FDA for the authorisation of the marketing 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
• Leading the development of technical documentation, with the support of specialised personnel
• Maintain the quality system, procedures and records in the different areas of ISO 9001 and 134585 standards, as well as the new EU regulation 2017/746
• Participate in both internal and external audits with the notified body
• Identification and control of legal and regulatory requirements in collaboration with the 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 contract
• Full time
• Possibilities for professional growth and development
• Working in a multidisciplinary team and in a company with a lot of projection

 
Candidate profile:

Required:

• Bachelor’s degree or equivalent in medicine, pharmacy, biology, chemistry or biochemistry
• Specialisation in clinical analysis via MIR/FIR/BIR/QIR
• Advanced English level

 
It will be an asset:

• Knowledge of ISO 9001:2015 and 13485:2016 quality management systems
• Knowledge of EU regulation 2017/746 on in vitro diagnostic medical devices
• Experience in Regulatory Affairs and Quality position in medical devices

  

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, etc.

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.