Quality Assurnace and Regulatory Affairs Lead

• £60k - 65k per year

Job Title: Quality Assurance and Regulatory Affairs Lead

Salary: £60,000 – £65,000

Location: London, UK

Job Type: Permanent

A London based Start-up Medical Device company developing a Class 1 Measuring Device is on the look out for a Quality and Regulatory Lead to join their growing business. They are looking for an individual that is hard working and self motivated to assist with all things QARA.

Key Responsibilities:

• Developing and executing regulatory strategies for FDA clearance, followed by other markets.
• Installing and marinating an appropriate QMS (including risk management processes). This is likely to be compliant with ISO 13485 and CFR21 Part 820.
• Oversee internal audits and manage external inspections by notified bodies and regulatory authorities.
• Manage regulatory documentation, including submission dossiers, technical files, and risk management files (ISO 14971).
• Provide guidance on Verification and Validation activities, ensuring alignment with FDA and international standards (e.g., ISO 60601, ISO 10993).
• Ensure product labeling, packaging, and instructions for use (IFU) meet regulatory requirements for the US and other markets.

Experiences and Qualifications Required:

• Proven experience in QARA including preparing and submitting regulatory submissions and installing and managing a QMS.
• Familiarity with global medical device regulations, including CFR 21, EU MDR and UKCA, and associated market requirements.
• Experience with common international standards for electronic medical devices (ISO 13485, 14971, 10933, 60601).
• Experience with external audit of quality and risk management systems.

Interviews: Starting in January

How to apply: Apply to e.smailes@x4lifesciences to learn more about the role or connect with me on LinkedIn to hear about regular job updates available with X4 Life Sciences.