Quality Assurance Lead (Permanent)

Job Title: Quality Assurance and Regulatory Affairs Lead Salary: £60,000 - £65,000
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.
Developing and executing regulatory strategies for FDA clearance, followed by other markets.
Installing and marinating an appropriate QMS (including risk management processes).
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).
Ensure product labeling, packaging, and instructions for use (IFU) meet regulatory requirements for the US and other markets.

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