Axial3D Belfast, Northern Ireland, United Kingdom

QARA Associate

Axial3D Belfast, Northern Ireland, United Kingdom

2 weeks ago Be among the first 25 applicants

Axial3D is looking for a motivated and detail-oriented Quality Assurance & Regulatory Affairs (QARA) Associate to join our growing QARA team. The QARA Associate will be integral in ensuring the quality and regulatory compliance of our products throughout their lifecycle. Reporting to the Head of QARA, the successful candidate will have foundational knowledge in regulatory standards and quality assurance processes, with a keen interest in the healthcare industry. The ideal candidate will support the QARA team in various regulatory activities and ensure compliance with relevant standards.

The Company

Axial3D is headquartered in Belfast, Northern Ireland and provides advanced solutions to medical device companies and other healthcare organisations worldwide. Specialising in the delivery of 3D anatomical model software and services, Axial3D enables device manufacturers particularly in orthopaedics and cardiovascular fields to seamlessly integrate personalised 3D models into their product development, planning, and clinical workflows. Our cloud-hosted, machine learning-based platform supports innovation by enhancing preoperative planning, improving device fit and function, and accelerating time to market. By embedding 3D technologies into the heart of surgical care pathways, Axial3D helps

transform patient outcomes through greater precision and personalisation.

The Role

As a QARA Associate you will:

• Perform routine quality checks and assessments on products to ensure compliance with established quality standards and relevant regulatory requirements.
• Assist in maintaining and organizing quality assurance documentation, including Standard Operating Procedures (SOPs), work instructions, quality records, and regulatory filings.
• Support the preparation and coordination of internal and external audits, including documentation, audit trails, and corrective action responses.
• Stay informed about industry regulations, standards, and best practices, particularly in medical device quality and regulatory compliance.
• Participate in the creation and maintenance of risk management activities, including risk assessments and mitigation strategies for product-related issues.
• Contribute to the development and delivery of training materials on quality management systems (QMS), regulatory standards, and quality assurance processes.
• Assist in investigating and resolving quality-related issues, non-conformities, and
• customer complaints, ensuring that effective corrective actions are implemented.
• Monitor and report on quality performance, identifying trends or issues and working to improve overall product quality.
• Support the change control process by evaluating the impact of changes on quality management systems and regulatory compliance.
• Ensure compliance with global regulatory requirements for product registration, including supporting the submission process for regulatory approvals.

For this opportunity you should have:

• Minimum of 1-3 years of experience in quality assurance, regulatory affairs, or a related field, preferably within the medical device or healthcare industry.
• Basic understanding of ISO 13485, FDA regulations, and other industry-specific standards (e.g., MDD, MDR, 21 CFR Part 820).
• Bachelor’s degree in a related field (e.g. Life Sciences, Medical Engineering)
• Familiarity with regulatory submission processes and documentation.
• Experience in assisting with internal audits, CAPA processes, or change control procedures.
• Strong analytical skills with the ability to assess regulatory compliance and identify areas for improvement.
• Excellent written and verbal communication skills, with the ability to interact effectively across teams.
• Attention to detail and ability to work in a fast-paced, deadline-driven environment.
• Proficiency with Microsoft Office Suite (Excel, Word, PowerPoint); knowledge of QMS software is a plus.

Location: Belfast, Northern Ireland.

The Opportunity

Axial3D is a rapidly growing and award-winning start-up and its success is built on the desire, determination, and talent of its employees.

It’s a fun and growing team and Axial3D offers the opportunity for your ideas to be implemented and to be recognized and rewarded for your achievements. We are a diverse group of people committed to making a real impact on people’s lives. We build products for everyone and do not discriminate on gender, ethnicity, sexual orientation, religion, civil or family status, age, disability, or race.

This position is ideal for a candidate who wishes to gain exposure and experience in all areas of QARA, and who wishes to work in a thriving, friendly and evolving company.

This position comes with an attractive remuneration package.

Please note: Applicants must have the legal right to work in the United Kingdom at the time of application. We are unable to offer visa sponsorship for this role. The position is based in Belfast and follows a hybrid working model, requiring regular attendance at our Belfast office (typically 2–3 days per week).

Seniority level

• Seniority level

  Entry level

Employment type

• Employment type

  Full-time

• Industries

  Medical Device

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