Head of QAra Biotechnology - Remote

Our client is a start-up that develops accelerated solutions for the diagnosis of bacterial infections.

As part of its rapid growth and the industrialization of its products, the company is looking for a Head of QARA. You will be responsible of the implementation of company’ s QMS covering all steps of a product life, from design to manufacturing and post marketing.

Your mission : As Head of QARA you will be responsible for:

• Leading the regulatory approval in both Europe and USA
• Managing of a team with employees, international partners and consultants involved in the project
• Deploying and maintaining a Quality System compliant with EU (ISO 13485) and USA (cGMP, 21 CFR 820) Design Controls and product development cycle regulations
• Bringing innovative ideas and processes to implement a QMS for a world-class instrument for direct blood pathogen detection and antibiotic susceptibility testing
• Ensuring the process validation of each manufacturing steps, especially for the industrialization stage
• Passing notified bodies regulatory audits

Your profile :

• Solid IVD experience (10 years, preferentially in a leading position for an analytical system QMS development)
• Expertise in leading all documentation efforts needed for regulatory agencies
• Successful track record of deploying and maintaining a Quality System in EU and the USA
• Obtaining at least one European regulatory approval for an IVD system.
• Used to the importance of sterility and contamination control.
• Proven track record of passing notified bodies regulatory audits.
• Experience obtaining Regulatory approvals of molecular diagnostics (PCR) and / or AST (Antimicrobial Susceptibility Testing)
• Leadership and able to build constructive discussions with other company division (Reagents, medical affairs, engineering, and operations)
• Management experience in leading internal teams and external partners (industrial and consultants)

If you want to join a fast-growing start-up developing an innovative IVD solution, contact us !

Information : Type de contrat : Temps plein

Lieu : Barcelona, Cataluña (Télétravail)

Catégorie : Other

Date affichée : 07/10/2023