Project Manager - Internal Systems & AI

The Project Manager is responsible for leading and delivering strategic projects focused on internal systems within a Notified Body environment for medical device certification. This role plays a critical part in driving digital transformation, including the development and implementation of AI-enabled solutions and end-to-end (E2E) system improvements that support certification processes.

The position requires strong cross-functional collaboration, ensuring alignment between technical, operational, legal, and leadership teams while maintaining compliance with regulatory requirements.

Project Delivery & Management

• Lead the planning, execution, and delivery of internal systems projects, ensuring they are completed on time, within scope, and within budget
• Manage full project lifecycles, from concept and requirements gathering through to implementation and post-delivery review
• Develop and maintain detailed project plans, timelines, risk registers, and status reports

AI & Digital Transformation

• Drive the development and integration of AI-based solutions to improve efficiency, accuracy, and scalability of certification processes
• Identify opportunities for automation and innovation across internal systems and workflows
• Work closely with IM, IT and data teams to ensure robust, secure, and compliant AI system deployment

End-to-End (E2E) Process Improvement

• Oversee projects that span the full certification & testing lifecycle, including:
• Client onboarding and initial contact
• Scheduling of audits and technical assessments
• Reporting and certification outputs
• Ensure systems are aligned to support seamless, efficient, and compliant end-to-end processes

Stakeholder Management

• Collaborate with a wide range of stakeholders, including:
• Continuous Improvement Manager within the Business Field
• Technical specialists within the Business Field (e.g., engineers, certifiers, product specialists, auditors)
• Legal and compliance teams
• IM, IT and systems development teams
• Senior leadership and executive management
• Act as a key point of contact, ensuring clear communication and alignment across all parties

Reporting & Governance

• Provide regular updates to senior management on project progress, risks, and outcomes
• Ensure all projects adhere to regulatory requirements relevant to medical device certification (e.g., MDR/IVDR frameworks)
• Support governance processes, including documentation, audit readiness, and quality management system alignment

Risk & Change Management

• Identify, assess, and mitigate project risks and issues
• Manage change effectively, ensuring stakeholder buy-in and minimal disruption to business operations

Essential:

• Proven experience as a Project Manager or leading projects, ideally within regulated environments (e.g., medical devices, healthcare, or certification bodies)
• Strong understanding of end-to-end business processes and systems implementation
• Experience delivering IT and/or digital transformation projects
• Ability to manage complex stakeholder environments across technical and non-technical teams
• Excellent communication, organisational, and problem-solving skills

Desirable:

• Experience working within a Notified Body or medical device certification environment
• Familiarity with AI, automation, or data-driven systems
• Knowledge of regulatory frameworks such as MDR and IVDR