QARA Software Engineer - Medical Devices, Onsite 4x/wk

Foundation Partners; Comberton; On-site; GBP 70,000 - 90,000; Full time

Benefits offered by this job

Onsite gym

EMI equity program

Comprehensive medical coverage

Optional remote Wednesdays (10 remote‑

Annual training budget

Beautiful Cambridgeshire office

Job summary

Flok Health is seeking a QARA Engineer to take ownership of quality and regulatory initiatives. You will apply an engineering approach to build tools and processes that support medical device development, with close collaboration across clinical, product and engineering teams.

The role emphasizes user‑centric design and practical application of ISO standards. This is an in‑office role four days a week in Cambridgeshire, with opportunity to shape regulatory workflows and device documentation.

Qualifications

• ISO standards familiarity (13485, 14971, 62304) and how they map to daily activities
• Experience applying engineering approaches to regulatory processes
• Ability to design, implement and improve regulatory workflows
• Experience building internal tools to support quality and regulatory activities
• Documentation activity including technical file content, risk management, and V&V

Responsibilities

• Know ISO 13485, 14971, 62304 and map to day‑to‑day Flok activities
• Design, implement and improve processes to meet regulatory requirements
• Collaborate with clinical, product and engineering teams to reduce friction
• Build internal tools to streamline quality/regulatory workflows
• Support device technical file documentation including change control, risk management and V&V

Skills

Software engineering background

User-centric mindset

Job description

Flok Health is seeking a QARA Engineer to take ownership of quality and regulatory initiatives. You will apply an engineering approach to build tools and processes that support medical device development, with close collaboration across clinical, product and engineering teams.

The role emphasizes user‑centric design and practical application of ISO standards. This is an in‑office role four days a week in Cambridgeshire, with opportunity to shape regulatory workflows and device documentation.