QA/RA Assistant – £28,000 depending on experience + Benefits – Liverpool

The Role

Are you looking to kickstart your career in quality management and regulatory affairs within the medical device industry?

MyCardium is offering an exciting opportunity for a QA/RA Assistant to join our team and play a key role in ensuring compliance with international regulatory standards and maintaining the high quality of our products.

You will work alongside our Quality and Regulatory Affairs team to help maintain certifications, regulatory approvals, and ensure adherence to key. This is a dynamic and varied role where you’ll contribute to a wide range of activities, from internal audits and training delivery to vendor management and regulatory documentation maintenance.

Note: Must have the right to work in the UK. Unfortunately, we cannot offer sponsorship for this role.

If you’re passionate about quality management and regulatory affairs, and ready to contribute to the success of a leading medical device company, we want to hear from you!

Key Responsibilities:

• Assist in maintaining compliance with certifications and regulatory approvals such as ISO 27001, ISO 9001, ISO 13485, UKCA, CE, and FDA 510(k).
• Support the update and maintenance of QMS and ISMS documentation.
• Help coordinate and conduct internal audits, document findings, and ensure corrective actions are followed up on.
• Deliver basic QMS/ISMS training to staff, including during induction sessions.
• Assist in vendor approval processes and monitor adherence to MyCardium’s quality standards.
• Support post-market surveillance activities in collaboration with the sales and marketing teams.
• Maintain essential regulatory documentation for audits and inspections.
• Provide general administrative support to the Quality and Regulatory Affairs team.

The Company

Founded in 2022, MyCardium AI is a spin-out from University College London. Our aim is to transform healthcare delivery using AI for cardiac MRI and Echo analysis. We're a passionate team committed to excellence, innovation, and creating a positive and inclusive work environment.

The Person

• Degree or equivalent qualification in Life Sciences, Quality Management, or a related field.
• 2+ years of relevant experience is preferred.
• A basic understanding of ISO standards or medical device regulations is desirable.
• Excellent organisational skills with strong attention to detail.
• Clear written and verbal communication abilities.
• A commitment to following procedures and maintaining accurate records.
• An interest in quality management, regulatory affairs, or compliance.