Regulatory & Quality Lead for MedTech AI

Jack & Jill/External ATS; Greater London; On-site; GBP 55,000 - 70,000; Full time

Job summary

A leading MedTech AI startup is looking for a Regulatory & Quality Specialist to act as the first regulatory hire. This role involves bridging healthcare compliance with cutting-edge AI technology, ensuring product quality, and shaping compliance strategies. The ideal candidate will have over 4 years of experience in MedTech regulatory roles and knowledge of ISO 13485. This position presents an exceptional opportunity to lead internal compliance initiatives and influence product development.

Qualifications

• 4+ years in MedTech regulatory or quality roles with experience in EU MDR or FDA 510(k) submissions.
• Strong understanding of ISO 13485 and compliance principles.
• Ability to leverage technology to solve regulatory challenges.

Responsibilities

• Collaborate with AI engineers to validate outputs and extract regulatory requirements.
• Research regulatory updates to guide product strategy.
• Lead compliance initiatives to maintain critical certifications.

Skills

MedTech regulatory experience

ISO 13485 knowledge

Ability to explain compliance principles

AI-native mindset

Research skills

Job description

A leading MedTech AI startup is looking for a Regulatory & Quality Specialist to act as the first regulatory hire. This role involves bridging healthcare compliance with cutting-edge AI technology, ensuring product quality, and shaping compliance strategies. The ideal candidate will have over 4 years of experience in MedTech regulatory roles and knowledge of ISO 13485. This position presents an exceptional opportunity to lead internal compliance initiatives and influence product development.