Quality Regulatory Manager

Freelance QARA Manager (Medical Devices)

1 day per week | Fully Remote | UK-based company (Wirral HQ)

We’re supporting an early-stage medical device company preparing for commercialisation and looking to engage an experienced Freelance Quality & Regulatory Affairs Manager on a part-time basis (1 day per week).

This role is ideal for someone who has built Quality Management Systems from scratch in a startup or scale-up medical device environment and can confidently lead the business through readiness for ISO 13485 certification, UK MHRA compliance, and US market requirements.

• Build and implement a QMS from the ground up aligned to ISO 13485
• Establish design controls, risk management, and document control frameworks
• Prepare the organisation for commercialisation readiness
• Lead regulatory strategy for UK (MHRA) and US markets
• Support technical documentation, SOP creation, and quality processes
• Act as the go-to QARA expert, advising founders and technical teams
• Provide pragmatic, proportionate quality solutions suited to a startup environment

• Strong experience in medical device QARA, ideally within startups or early-stage companies
• Proven track record of implementing ISO 13485 QMS from scratch
• Hands-on experience with UKCA / MHRA and US regulatory pathways
• Comfortable working autonomously and influencing without bureaucracy
• Practical, delivery-focused mindset rather than “big corporate” only experience
• Freelance / Contract
• Fully remote (UK-based company, HQ in Wirral)
• Flexible engagement with long-term potential

If you’re a senior QARA professional who enjoys building systems, shaping quality culture, and supporting innovative medical device companies at a critical growth stage, this is a great opportunity.