Quality & Regulatory Associate – Medical Devices

About the role

Our client, a fast‑growing med‑tech company in Manchester, is looking for a Quality & Regulatory Associate to help optimise their Quality Management System and prepare for ISO 13485 certification and FDA 510(k) submissions. You will work closely with internal teams to ensure quality and regulatory requirements are met while supporting continuous improvement.

Key responsibilities

• Support day‑to‑day operation of the ISO 13485 QMS.
• Assist with preparation of FDA 510(k) technical documentation.
• Maintain design file history and technical documentation.
• Manage quality documentation, change controls and CAPA processes.
• Prepare materials for internal readiness reviews and external audits.
• Promote continuous improvement in quality processes.

Required profile

• Prior experience in Quality Assurance or Regulatory Affairs within the medical devices or med‑tech sector.
• Pragmatic, delivery‑focused mindset with strong problem‑solving abilities.
• Excellent communication skills and meticulous attention to detail.
• Willingness to work on‑site at least three days per week.

Required skills

• ISO 13485 QMS knowledge.
• FDA 510(k) documentation preparation.
• Design controls and Design History Files management.
• CAPA (Corrective and Preventive Action) processes.

What we offer

• Permanent full‑time role with a salary of £35,000‑£45,000 per year, dependent on experience.
• Hybrid working model (minimum three days on‑site).
• Opportunity to grow with the business as it scales.
• Exposure to both UK and US regulatory environments.