Regulatory Affairs Manager

Alfa AI; West of England; Hybrid; GBP 65,000 - 90,000; Full time

Job summary

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

Qualifications

• 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.

Responsibilities

• 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.

Skills

Regulatory submissions

UK/EU/US pathways

ISO 14971

ISO 13485

Regulatory authorities liaison

Right to work UK

Job description

Are you ready to steer innovative Software as a Medical Device (SaMD) through complex global regulatory pathways? Sustainable Infrastructure is seeking for their Bristol client an experienced Regulatory Affairs Manager to take ownership of our digital health regulatory strategies and lifecycle submissions. Based in Bristol with a balanced hybrid setup (two days per week on-site alongside remote working), this full-time, permanent position places you at the intersection of clinical insight, software development, and international compliance. In this critical role, you will define classification pathways, drive core submissions across key target markets, and ensure our cutting-edge health software products meet rigorous safety and performance standards from concept through post-market operations. Please note that visa sponsorship is not available for this position.

Key Responsibilities

• Lead global regulatory submissions for Software as a Medical Device (SaMD) products, authoring clear documentation and orchestrating decisive responses to reviewer inquiries.
• Define and implement robust multi-market regulatory strategies, classifications, and clinical evidence roadmaps covering the UK (MHRA), EU (EU MDR / CE marking), and US (FDA 510(k)).
• Evaluate technical software files, clinical evaluation documentation, and ISO 14971 risk management records to perform gap analyses and resolve submission deficiencies.
• Act as the primary liaison managing interactions, technical meetings, and substantive discussions with Notified Bodies, conformity assessment bodies, and regulatory authorities.
• Collaborate closely with cross-functional product, engineering, and clinical teams to achieve scheduled regulatory milestones and maintain project momentum.
• Direct post-market surveillance activities, assess product change impacts, and ensure continuous compliance throughout the digital health software lifecycle under ISO 13485.

Required Skills & Experience

• Substantial direct experience managing end-to-end regulatory submissions and reviewer responses for Software as a Medical Device (SaMD) within digital health.
• Proven track record establishing regulatory pathways and handling submissions across the UK, EU MDR, and US FDA (such as 510(k) clearances and CE marks).
• In-depth expertise in reviewing software documentation, risk management files (ISO 14971), and clinical evaluation data for audit and submission readiness.
• Hands-on experience liaising directly with regulatory authorities (e.g., MHRA, FDA) and Notified Bodies or conformity assessment bodies.
• Practical understanding of Medical Device Quality Management Systems grounded in ISO 13485, with an emphasis on driving regulatory delivery.
• Existing right to work in the UK without requiring sponsorship.

Nice-to-have

• Exposure to digital health product development sprints and agile software environments.
• Practical experience coordinating or hosting external regulatory audits.
• Familiarity with evolving international cybersecurity and artificial intelligence frameworks for medical software.

What We Offer / Why Join

At Sustainable Infrastructure's client, you will hold direct responsibility for taking advanced software devices from initial strategy through global regulatory clearance. Working in a collaborative hybrid structure, you will act as the key regulatory subject matter expert, shaping product architecture, guiding clinical partners, and ensuring our digital health innovations achieve their full regulatory potential.