Hybrid SaMD Regulatory Manager – Global Submissions

Sustainable Infrastructure; Bristol; Hybrid; GBP 55,000 - 75,000; Full time

Benefits offered by this job

Hybrid working

10% bonus

Job summary

Sustainable Infrastructure in Bristol seeks a hands-on Regulatory Affairs Manager with SaMD experience to lead regulatory submissions and shape international regulatory strategy for medical software products.

You will own regulatory documentation, define pathways for UK, EU and US markets, and collaborate with software, clinical, and quality teams to ensure submissions are robust and compliant throughout the lifecycle.

Qualifications

• Hands-on regulatory professional with SaMD experience
• Experience preparing regulatory submission documentation
• Knowledge of UK/EU medical device frameworks and FDA requirements
• Strong writing skills and attention to detail

Responsibilities

• Lead regulatory submissions for SaMD products in UK, EU and US.
• Develop regulatory strategies and device classifications for priority markets.
• Prepare regulatory documentation and respond to regulator questions.
• Support FDA submissions, incl. 510(k) and De Novo where possible.
• Review software docs, clinical evidence and risk management data for submissions.
• Manage interactions with regulators and Notified Bodies.
• Collaborate with software, clinical, product and quality teams to meet milestones.
• Assess regulatory impact of product changes and lifecycle compliance.

Skills

SaMD Regu­latory

FDA Submissions

UK/EU MDR

Regulatory Writing

Cross-functional Collab

Job description

Sustainable Infrastructure in Bristol seeks a hands-on Regulatory Affairs Manager with SaMD experience to lead regulatory submissions and shape international regulatory strategy for medical software products.

You will own regulatory documentation, define pathways for UK, EU and US markets, and collaborate with software, clinical, and quality teams to ensure submissions are robust and compliant throughout the lifecycle.