MedTech QA/Regulatory Associate — ISO 13485 & FDA Prep

ScubaTx Limited; Manchester; Hybrid; GBP 28,000 - 42,000; Full time

Benefits offered by this job

Flexible working arrangements

Direct exposure to ISO 13485 readiness

FDA 510(k) preparation experience

Growth opportunities

Job summary

ScubaTx Limited is seeking a hands-on Quality & Regulatory Associate to support the execution of our QMS and regulatory activities as we progress ISO 13485 readiness and FDA 510(k) preparation. This role is execution-focused, supporting external QA/RA consultants and internal teams to ensure documentation, design controls and quality processes are implemented accurately and on time.

This is a junior–mid level position with flexible working arrangements in Manchester and opportunities to grow

Qualifications

• Experience in Quality Assurance or Regulatory Affairs within regulated healthcare tech.
• Exposure to product development, design controls, or technical documentation.
• Hands-on experience supporting an ISO 13485 QMS.
• Familiarity with design controls and DHF structures and strong documentation.
• Ability to coordinate across technical and non-technical teams.

Responsibilities

• Operate ISO 13485–aligned QMS day-to-day.
• Maintain controlled documents, records and templates.
• Coordinate document reviews, approvals and version control.
• Support design controls, change control and CAPA processes.
• Prepare evidence packs for internal readiness reviews and external audits.
• Track actions and remediation from audits.
• Support DHF population and technical documentation.
• Coordinate inputs from engineering, software and systems.
• Assist FDA 510(k) and UK/EU technical docs preparation.
• Coordinate with operations and engineering to ensure evidence is complete.

Skills

Quality Assurance/Regulatory Affairs

ISO 13485

Documentation writing

Cross-functional coordination

Regulatory submission support

Attention to detail

Job description

ScubaTx Limited is seeking a hands-on Quality & Regulatory Associate to support the execution of our QMS and regulatory activities as we progress ISO 13485 readiness and FDA 510(k) preparation. This role is execution-focused, supporting external QA/RA consultants and internal teams to ensure documentation, design controls and quality processes are implemented accurately and on time.

This is a junior–mid level position with flexible working arrangements in Manchester and opportunities to grow