QA/ RA Specialist

Description: Responsibility for the quality and regulatory framework in a medical device company. The position includes building and maintaining the Quality Management System (QMS), supporting development processes according to regulatory and standards requirements, preparing documentation for regulatory submissions, and supporting internal and external audits.

The candidate will be working on ensuring the company’s compliance with international standards and regulatory requirements, leading quality processes throughout the product lifecycle.

Key Responsibilities

• Establish, maintain, and continuously improve the Quality Management System in accordance with ISO 13485, FDA 21 CFR Part 820, MDR, and additional standards.
• Provide full support for Design Control processes, documentation management, supplier qualification and evaluation
• Support training and qualification activities
• Prepare and maintain regulatory documentation including Technical Files, , IFU, labeling, Design History File (DHF), and SOPs.
• Support preparation of regulatory submissions such as 510(k), CE marking
• Support all production activities: Monitoring the production process, Equipment calibration and maintenance, Manage non-conformances (NC), handle CAPA activities, conduct internal audits, and prepare the organization for external audits.
• Support R&D, V&V, and manufacturing teams in maintaining quality and regulatory processes.
• Oversee and approve change processes (ECR/ECO), product documentation, and change management activities. Monitor regulatory changes and update the system accordingly.

Requirements

• Bachelors degree in science or bio medical engineering
• 2-3 Proven experience in QA/RA roles within a Medical Device company – mandatory.
• Strong familiarity with standards: ISO 13485, ISO 14971, IEC 62304, FDA QMSR; advantage for IEC 60601,.
• Support preparation regulatory documents including V&V documentation
• Solid understanding of development processes, V&V, and engineering documentation management.
• High-level English (professional reading and writing).
• Excellent organizational skills, accuracy, independence, and the ability to prioritize in a dynamic environment.
• Strong interpersonal communication and ability to work with multiple internal and external stakeholders.

Nice to Have

• Experience in start-up environments or rapidly changing settings.
• Experience working with external test labs (EMC, Electrical Safety, biocompatibility and more).
• Proven experience in Clinical Affairs- Advantage

Reports to: QA/RA Lead