our client

We are partnering with an innovative, fast-growing international HealthTech & Precision Oncology company. They specialize in developing cutting-edge Next-Generation Sequencing (NGS) software and diagnostic solutions aimed at democratizing advanced cancer care globally.

your functions

This position is responsible for maintaining and ensuring that the company's quality system complies with FDA, EU, ISO 13485, IEC 62304, and all international medical device and IVD market requirements. The QARA Specialist is also responsible for ensuring that products and their labeling meet all regulatory requirements (both domestic and international).
Key responsibilities include the independent management of QMS ISO standards and audits. Furthermore, the role will involve leading regulatory submissions to secure IVDR certification.
The successful candidate must possess a broad range of technical and scientific knowledge, with proven experience in ISO 13485 and IEC 62304. The ability to identify and quickly adapt to changing priorities is essential.

position requisites

• Formación

  : Grado

• Conocimientos

  : iso 13485, iso 62304

• Experiencia

  : 5 años

- Experience: Minimum of 5+ years of hands-on experience in QARA roles within the Medical Device, In Vitro Diagnostics (IVD), or digital health/SaMD industries.
- Education: Bachelor¿s or Master¿s degree in Biomedical Engineering, Computer Science, Biotechnology, Pharmacy, or a related scientific/technical discipline.
- CE-IVDR Expert: Deep knowledge and direct experience with the transition to and compliance with IVDR (EU 2017/746) and/or MDR (EU 2017/745).
- SaMD / Digital Health: Direct experience regulatory-filing for Software as a Medical Device (SaMD).
- Global Submissions: Proven track record preparing technical documentation for CE marking.

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