QA/RA Specialist

NES Fircroft is looking for a QA/RA specialist to join an high-end technology supplier specializing in medical technology, biotechnology, and in-vitro diagnostics . Our client provide contract engineering and manufacturing services, covering the entire product development process from concept to production.

Responsibilities

• Ensure compliance with international regulatory standards (e.g., ISO 13485, MDR, FDA 21 CFR Part 11) for medical devices.
• Develop, implement, and maintain Quality Management System (QMS) processes and documentation.
• Prepare and submit regulatory filings, technical documentation, and product registrations.
• Conduct internal audits and support external audits from notified bodies and regulatory authorities.
• Monitor and interpret changes in relevant regulations and standards, ensuring timely implementation.
• Collaborate with cross-functional teams (R&D, Manufacturing, Clinical) to ensure regulatory and quality requirements are met throughout the product lifecycle.
• Manage risk assessments, CAPA (Corrective and Preventive Actions), and non-conformance reports.
• Support product labeling, IFU (Instructions for Use), and compliance with UDI requirements.
• Provide training and guidance on quality and regulatory processes to internal teams.

Requirements

• Bachelor’s or Master’s degree in Biomedical Engineering or similar.
• Minimum 2–3 years of experience in QA/RA roles within the MedTech or medical device industry.
• Strong knowledge of ISO 13485, EU MDR, and FDA regulations.
• Experience with QMS implementation and maintenance.
• Excellent documentation and organizational skills.
• Proficiency in English (written and spoken); additional languages are a plus.