Risk & Assurance Specialist

Crux Product Design; West of England; On-site; GBP 70,000 - 100,000; Full time

Benefits offered by this job

Travel opportunities to support global

Collaborative culture

Global project delivery

Job summary

Crux Product Design Ltd is seeking an experienced risk, governance, and assurance professional to lead risk management and assurance activities across our global operations. Reporting to the Head of Quality, Regulatory, Risk & Assurance, you will collaborate with leaders across the organisation to identify, assess, monitor, and mitigate risks while enabling growth in a compliant, safe and efficient manner.

You will drive horizon-scanning, governance for confidentiality and IP, and coordinate

Qualifications

• Degree or equivalent experience in a relevant discipline.
• Experience in governance, assurance, risk management or compliance activities.
• Experience delivering assurance activities for leadership reporting.
• Experience working with cross-functional stakeholders in regulated environments.
• Strong stakeholder management and communication skills.

Responsibilities

• Own and develop the business risk and assurance framework across the organisation, ensuring governance, risk and assurance activities are aligned and consistently applied.
• Maintain and facilitate the company risk management process, ensuring significant risks are identified, assessed, assigned, owned and reviewed.
• Monitor emerging regulatory, technology, governance and operational risks, providing horizon-scanning insights for decision making.
• Support governance relating to clinical and pre-clinical research, research ethics, patient safety and adverse event management.
• Establish and oversee governance processes relating to confidentiality, IP, conflicts of interest and sensitive client information.
• Coordinate assurance activities relating to insurance, liability exposure, international expansion and overseas operations.
• Prepare risk and assurance reporting for leadership teams, highlighting trends and emerging risks.
• Coordinate internal assurance reviews and track corrective and improvement actions.
• Apply Plan-Do-Check-Act methodology to governance and assurance programmes.
• Act as project manager for risk management and assurance initiatives and monitor actions.
• Oversee change management, risk and opportunity registers, policies, and RFIs.
• Maintain Firewall Owner oversight for projects with Independent Development controls.

Skills

Governance

Risk management

Regulatory compliance

Stakeholder management

Communication

Education

Degree or equivalent in quality, governance, risk, compliance, science, engineering or business management

Tools

Power BI

Power Automate

Job description

Position Overview

Are you passionate about helping organisations identify, manage and mitigate risk while strengthening resilience and supporting sustainable growth? Join Crux and play a key role in developing and embedding risk management and assurance practices across our global business.

Reporting directly to the Head of Quality, Regulatory, Risk & Assurance (QRRA), you will work closely with business leaders across the organisation to lead risk management and assurance activities across all aspects of Crux's global operations.

Working with stakeholders across the business, you will proactively identify and assess risks, coordinate assurance activities, monitor emerging risks and support the implementation of effective controls to ensure the business continues to operate safely, compliantly and efficiently.

At Crux, we believe curiosity drives innovation. As a specialist consultancy supporting world-leading medical device and consumer product organisations, we combine technical excellence with a collaborative culture to deliver innovative solutions that improve lives. We are looking for an experienced professional who can help ensure our risk, assurance and governance practices evolve alongside our growing international business, enabling informed decision-making and supporting long‑term business resilience.

Why Crux?

• Work with top pharma clients on cutting‑edge medical device projects.
• Collaborate with a multidisciplinary team across our Bristol (UK) and Boston (US) offices.
• Travel opportunities to support global project delivery
• Influence the development of life‑changing healthcare technologies
• Be part of a consultancy that values curiosity, integrity, and collaboration

Principal Responsibilities

• Own and develop the business risk and assurance framework across the organisation, ensuring governance, risk and assurance activities are aligned and consistently applied.
• Maintain and facilitate the company risk management process, working closely with business leaders across the organisation to ensure significant risks are identified, assessed, assigned, appropriately owned and periodically reviewed.
• Monitor emerging regulatory, technology, governance and operational risks, providing horizon‑scanning insights to support proactive decision making.
• Support governance activities relating to clinical and pre‑clinical research, research ethics, patient safety and adverse event management.
• Establish and oversee governance processes relating to confidentiality, intellectual property, conflicts of interest and sensitive client information.
• Coordinate assurance activities relating to insurance, liability exposure, international expansion and overseas operations, ensuring appropriate specialist input and risk ownership is established.
• Prepare risk and assurance reporting for leadership teams, highlighting key trends, emerging risks and areas requiring management attention.
• Coordinate internal assurance reviews and track the implementation of resulting corrective and improvement actions.
• Apply the Plan > Do > Check > Act methodology to governance and assurance programmes.
• Act as project manager for risk management and assurance initiatives, ensuring actions are effectively implemented and monitored.
• Oversee existing processes including change management, risk and opportunity registers, business policies, and client requests for information (RFIs).
• Act as Firewall Owner for projects subject to Independent Development controls, including oversight of conflict‑of‑interest assessments, maintenance of Firewall Registers, project onboarding activities and monitoring of firewall compliance.
• Maintain oversight of key business policies and controls, ensuring periodic review and organisational compliance.

What We’re Looking For

Essential

• Degree or equivalent experience in a relevant discipline such as quality, governance, risk, compliance, science, engineering or business management.
• Experience in governance, assurance, risk management or compliance activities, including business and operational risk identification and management.
• Experience delivering assurance activities, driving organisational improvement and preparing risk, assurance or compliance reporting for leadership teams.
• Experience working with cross‑functional stakeholders in a regulated environment.
• Strong stakeholder management and communication skills.

Desirable

• Experience developing or implementing governance, assurance or risk‑management frameworks.
• Knowledge of research governance, data protection, AI governance or business compliance activities.
• Experience using Power Automate, Power BI or similar tools to automate workflows and develop risk/compliance reporting.
• Demonstrated awareness and practical experience applying AI tools and workflows to streamline review and reporting activities.
• Experience managing projects and coordinating cross‑functional initiatives.
• Experience supporting international operations and cross‑border business activities.
• Internal auditing, continuous improvement or quality management experience.
• Professional qualifications in risk management, governance, compliance or project management.
• A proactive, curious and collaborative approach aligned with Crux values.

Why you'll love working here

We’re a dynamic, fast‑growing engineering consultancy with a reputation for delivering brilliant work and for being a genuinely great place to build your career.

Our benefits package is designed to support your wellbeing and work‑life balance. You’ll enjoy a generous holiday allowance, life assurance, a generous pension scheme, bike‑to‑work options, a health cash plan, enhanced family leave and opportunities to get involved in social events throughout the year.

Check out what an opportunity at Crux offers you: Life at Crux

We are committed to building a diverse and inclusive workplace where everyone feels valued and supported. We welcome applications from people of all backgrounds, including those with disabilities, and strive to create an environment where different perspectives and experiences help us grow.

We’re a Disability Confident employer. If you would like to make an application under the Disability Confident Scheme or need adjustments at any stage of the application and interview process (or once you join us!), just let us know and we’ll make sure you have the support you need.