Regulatory Affairs Manager

Sustainable Infrastructure; Bristol; Hybride; GBP 55 000 - 75 000; Plein temps

Avantages offerts par ce poste

Hybrid working

10% bonus

Résumé du poste

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

Responsabilités

• 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.

Connaissances

SaMD Regu­latory

FDA Submissions

UK/EU MDR

Regulatory Writing

Cross-functional Collab

Description du poste

Regulatory Affairs Manager

Location: Bristol, UK

Working Arrangement: Hybrid - office-based Wednesday and Thursday

Salary: £55,000-£75,000 per annum + 10% bonus

Employment Type: Permanent, Full-time

About the Company

An innovative medical technology company developing software-based solutions to support neurological assessment and clinical decision-making is looking for a Regulatory Affairs Manager to join its growing team in Bristol.

The business combines scientific research, clinical expertise and software technology to develop medical solutions with the potential to improve patient assessment and care.

This is an opportunity to join a specialist, fast-moving organisation where regulatory affairs plays a critical role in bringing innovative software medical devices to market.

The Role

We are seeking a hands-on Regulatory Affairs Manager with experience in Software as a Medical Device (SaMD) to lead regulatory submissions and support the international regulatory strategy for medical software products.

You will take ownership of preparing and writing regulatory documentation, defining appropriate regulatory pathways and coordinating evidence requirements across UK, EU and US markets.

Working closely with software, scientific, clinical, product and quality teams, you will ensure submissions are technically robust, regulatory requirements are met, and products remain compliant throughout their lifecycle.

This role would suit someone who enjoys working in a small or growing business, is comfortable taking ownership and can deliver practical regulatory solutions at pace.

Key Responsibilities

• Lead the preparation, writing and coordination of regulatory submissions for Software as a Medical Device (SaMD) products.
• Develop and recommend regulatory strategies, pathways and device classifications for priority UK, EU and US markets.
• Prepare regulatory documentation and respond to questions and requests for additional information from regulatory reviewers.
• Support FDA submissions, including 510(k) and, ideally, De Novo applications.
• Review software documentation, clinical evidence, verification and validation data, and risk-management documentation to identify and address submission gaps.
• Manage regulatory interactions and substantive discussions with regulators, Notified Bodies and other assessment bodies.
• Work collaboratively with software engineering, clinical, scientific, product and quality teams to deliver regulatory milestones.
• Assess product changes and determine their regulatory impact, maintaining compliance throughout the product lifecycle.
• Apply practical knowledge of ISO 13485 and relevant quality management processes to support regulatory delivery.
• Monitor relevant regulatory developments and translate requirements into practical actions for the business.

About You

We are looking for a proactive regulatory professional who combines strong technical writing skills with practical experience of bringing medical software products through regulatory processes.

Essential experience

• Hands-on experience in regulatory affairs for Software as a Medical Device (SaMD) or software-driven medical devices.
• Direct experience writing and preparing regulatory submission documentation, rather than solely overseeing external consultants or internal teams.
• Experience with FDA regulatory submissions, ideally De Novo, although 510(k) experience will also be considered.
• Knowledge of UK and EU medical device regulatory frameworks and an understanding of relevant US FDA requirements.
• Experience reviewing technical documentation, clinical evidence, software validation and risk-management records.
• Practical understanding of ISO 13485 and medical device quality management systems.
• Strong written communication skills, attention to detail and the ability to respond effectively to regulatory questions.
• Ability to work cross-functionally and manage regulatory deliverables independently.

Desirable experience

• Recent experience working in a startup, scale-up or small medical technology company.
• Experience supporting regulatory submissions with limited resources and tight timelines.
• Experience with innovative software-based medical devices, clinical decision-support tools or digital health products.
• Experience engaging directly with FDA reviewers, Notified Bodies or other regulatory assessment organisations.

What's on Offer?

• Competitive salary of £55,000-£75,000 per annum.
• 10% bonus.
• Hybrid working, with two set office days per week: Wednesday and Thursday.
• The opportunity to take ownership of regulatory submissions and influence international market access.
• A collaborative, science-led environment within an innovative medical technology business.
• The opportunity to make a meaningful contribution to the development and regulatory approval of software-based medical devices.