Global SaMD Regulatory Lead (Hybrid, Bristol)

ALFA AI GmbH; West of England; Hybrid; GBP 65.000 - 90.000; Vollzeit

Zusammenfassung

Sustainable Infrastructure seeks a Regulatory Affairs Manager for our Bristol client to lead global SaMD regulatory submissions, strategy, and lifecycle oversight. Hybrid role with on-site two days per week, you will coordinate UK, EU MDR/CE, and US FDA processes, ensuring safety and compliance from concept through post-market activities.

You will liaise with MHRA, FDA, and Notified Bodies, driving regulatory delivery across cross-functional teams and maintaining rigorous documentation and

Qualifikationen

• Direct experience managing end-to-end SaMD regulatory submissions and reviewer responses.
• Experience establishing regulatory pathways across UK, EU MDR, and US FDA.
• Reviewing software documentation, risk management (ISO 14971), and clinical evaluation data.
• Liaising with MHRA, FDA, Notified Bodies, and conformity assessment bodies.
• Understanding QMS per ISO 13485 with focus on regulatory delivery.
• Existing right to work in the UK without sponsorship.

Aufgaben

• Lead global regulatory submissions for SaMD products and coordinate reviewer inquiries.
• Define multi-market regulatory strategies covering UK, EU MDR/CE, and US FDA.
• Evaluate software files, risk management, and clinical evidence for gaps.
• Interact with regulatory authorities and Notified Bodies during submissions.
• Collaborate with product, engineering and clinical teams to hit milestones.
• Oversee post-market surveillance and impact assessments under ISO 13485.

Kenntnisse

Regulatory submissions

UK/EU/US pathways

ISO 14971

ISO 13485

Regulatory authorities liaison

Right to work UK

Jobbeschreibung

Sustainable Infrastructure seeks a Regulatory Affairs Manager for our Bristol client to lead global SaMD regulatory submissions, strategy, and lifecycle oversight. Hybrid role with on-site two days per week, you will coordinate UK, EU MDR/CE, and US FDA processes, ensuring safety and compliance from concept through post-market activities.

You will liaise with MHRA, FDA, and Notified Bodies, driving regulatory delivery across cross-functional teams and maintaining rigorous documentation and