Job Summary
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.
Reports to: Global Head of Projects – Medical
Hours: 20 hours per week minimum
Job Description
Project Delivery & Management
1. ■Lead the planning, execution, and delivery of internal systems projects, ensuring they are completed on time, within scope, and within budget
2. ■Manage full project lifecycles, from concept and requirements gathering through to implementation and post-delivery review
3. ■Develop and maintain detailed project plans, timelines, risk registers, and status reports
AI & Digital Transformation
4. ■Drive the development and integration of AI-based solutions to improve efficiency, accuracy, and scalability of certification processes
5. ■Identify opportunities for automation and innovation across internal systems and workflows
6. ■Work closely with IM, IT and data teams to ensure robust, secure, and compliant AI system deployment
End-to-End (E2E) Process Improvement
7. ■Oversee projects that span the full certification & testing lifecycle, including:
8. ■Client onboarding and initial contact
9. ■Scheduling of audits and technical assessments
10. ■Reporting and certification outputs
11. ■Ensure systems are aligned to support seamless, efficient, and compliant end-to-end processes
Stakeholder Management
12. ■Collaborate with a wide range of stakeholders, including:
13. ■Continuous Improvement Manager within the Business Field
14. ■Technical specialists within the Business Field (e.g., engineers, certifiers, product specialists, auditors)
15. ■Legal and compliance teams
16. ■IM, IT and systems development teams
17. ■Senior leadership and executive management
18. ■Act as a key point of contact, ensuring clear communication and alignment across all parties
Reporting & Governance
19. ■Provide regular updates to senior management on project progress, risks, and outcomes
20. ■Ensure all projects adhere to regulatory requirements relevant to medical device certification (e.g., MDR/IVDR frameworks)
21. ■Support governance processes, including documentation, audit readiness, and quality management system alignment
Risk & Change Management
22. ■Identify, assess, and mitigate project risks and issues
23. ■Manage change effectively, ensuring stakeholder buy-in and minimal disruption to business operations
Key Skills & Experience:
Essential:
24. ■Proven experience as a Project Manager or leading projects, ideally within regulated environments (e.g., medical devices, healthcare, or certification bodies)
25. ■Strong understanding of end-to-end business processes and systems implementation
26. ■Experience delivering IT and/or digital transformation projects
27. ■Ability to manage complex stakeholder environments across technical and non-technical teams
28. ■Excellent communication, organisational, and problem-solving skills
Desirable:
29. ■Experience working within a Notified Body or medical device certification environment
30. ■Familiarity with AI, automation, or data-driven systems
31. ■Knowledge of regulatory frameworks such as MDR and IVDR
We only accept applications submitted online through our application system. We cannot accept applications sent by email.
What else you should know
Job ID18907Type of contractPermanentType of employmentPart TimeWork modelFlex Office / partially remoteCompanyTUV Rheinland UK Ltd.
Application deadline: as long as the job is listed on our career page, we are looking for suitable candidates (all genders welcome). We are looking forward to receiving your application.