Our client is at the forefront of personalized medicine, developing cutting-edge Next-Generation Sequencing (NGS) software and AI-native diagnostic platforms designed to democratize advanced cancer care globally.

This position is
100% remote from anywhere in Spain
.

The Role

As a Senior QARA Specialist, you will bridge the gap between strict regulatory compliance and fast-paced software development. You will play a key role in maintaining their Quality Management System and driving regulatory pathways for cutting-edge Software as a Medical Device and In Vitro Diagnostics.

Key Responsibilities:
- Regulatory Compliance:
Prepare, review, and maintain technical documentation and regulatory submissions under
IVDR (EU 2017/746)
and general markets.
- QMS Management:
Drive and maintain the Quality Management System in accordance with
ISO 13485
.
- Software QA Integration:
Collaborate closely with Product and Engineering teams to ensure software development processes align with
IEC 62304
and
IEC 82304-1
in an agile,



cloud-based environment.
- Risk Management:
Lead and implement product risk management processes under
ISO 14971
.
- Auditing:
Prepare for and support external audits (Notified Bodies) and perform internal audits.

What We Are Looking For:
- Experience:
5+ years of hands-on experience
in Quality Assurance and Regulatory Affairs within the Medical Device, In Vitro Diagnostics (IVD), or Digital Health/SaMD sectors.
- Technical Standards:
Solid expertise in
ISO 13485
,
ISO 14971
, and
IEC 62304.
- Regulatory Track Record:
Direct experience working with
IVDR
and compiling CE-marking technical files.
- Languages:
Full professional proficiency in
English
(written and spoken) is a must, as you will collaborate with international teams and regulatory bodies.
- Location:
Must be based in
Spain
(with legal right to work).

📌 Senior QARA (España)
🏢 Randstad España
📍 España