Job Title: QA/RA Consultant – Medical Devices & IVD
Location: Fully Remote (Global)
Salary: Up to £55,000 (dependent on experience)
Job Type: Full-time, Permanent
About the Role
We are a growing Quality Assurance & Regulatory Affairs (QA/RA) consultancy supporting a diverse portfolio of global medical device and IVD clients. As part of our continued growth, we are seeking a QA/RA Consultant with a strong all-round regulatory and quality background to join our fully remote team.
This role is ideal for a science graduate with hands-on experience across EU regulatory requirements and U.S. submissions, who enjoys working on varied projects and collaborating with international clients.
Key Responsibilities
- Prepare and maintain EU Technical Documentation / Technical Files in line with MDR/IVDR requirements
- Support and contribute to U.S. FDA 510(k) submissions
- Provide QA/RA guidance to clients across the product lifecycle
- Assist with Quality Management System (QMS) development, implementation, and maintenance (e.g., ISO 13485)
- Support regulatory strategy and submission planning for global markets
- Participate in or support clinical trial activities where applicable
- Contribute to risk management, post-market surveillance (PMS), and vigilance activities
- Collaborate with cross-functional teams to ensure compliance and project delivery
Requirements
- Degree in a scientific discipline (e.g., Life Sciences, Biomedical Science, Engineering, or similar)
- Proven experience in a QA/RA role within medical devices and/or IVDs
- Strong working knowledge of EU MDR technical documentation / technical files
- Experience supporting or preparing FDA 510(k) submissions
- Understanding of quality systems (e.g., ISO 13485)
- Excellent organisational skills and attention to detail
- Ability to manage multiple projects in a fully remote environment
Desirable (Not Essential)
- Experience with IVDR
- Exposure to clinical trial / clinical affairs activities
- Knowledge of additional global regulatory frameworks (e.g., UKCA, Health Canada, TGA)
- Experience working within a consultancy environment
What We Offer
- Fully remote working with flexibility
- Opportunity to work with a wide range of global clients and technologies
- Varied and engaging project work across QA and regulatory disciplines
- Supportive, collaborative consultancy culture
- Competitive salary with scope for progression based on performance and experience
If you are a proactive QA/RA professional looking to broaden your experience across international regulatory frameworks and make an impact in a consultancy setting, we’d love to hear from you.
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