Regulatory Affairs and Quality Assurance Assistant

About the role

We are seeking a Regulatory Affairs and Quality Assurance Assistant to support a fast‑growing medical‑devices company in Cambridge. You will work closely with the QA and Regulatory Affairs Manager and the R&D team, providing guidance on product development and ensuring compliance with relevant standards.

Key responsibilities

• Assist the QA/Regulatory manager with day‑to‑day regulatory and quality activities.
• Provide advice to R&D on design processes and compliance requirements.
• Support preparation and coordination of FDA 510(k) and ISO 13485 documentation.
• Help maintain the Quality Management System (QMS) and ensure adherence to FDA 21 CFR Part 820.
• Relay information to teams responsible for regulatory submissions.

Required profile

• Degree (1st or 2:1) in engineering or a science discipline.
• Experience in regulatory affairs or quality assurance within medical devices.
• Familiarity with medical‑device design and development environments.
• Ability to work collaboratively with R&D and cross‑functional teams.

Required skills

• Knowledge of FDA 510(k) regulations.
• Understanding of ISO 13485 standards.
• Familiarity with FDA 21 CFR Part 820 requirements.
• Experience with Quality Management Systems (QMS).
• Medical‑device design process awareness.

What we offer

• Career progression in a growing company.
• Competitive salary and benefits package.
• Opportunity to work on life‑changing medical devices.
• Share options.