Trainee (Support Expert Panels on high-risk medical devices in new innovative activities)

About the traineeship programme

The Agency is looking for motivated, qualified recent graduates or students on an Erasmus+ or other programme or PhD students or Master's students (who posses a previous degree), who are interested in gaining experience and contribute to the Agency’s work for every patient in Europe. The purpose of a traineeship at the Agency is to perform tasks that are predominantly in the interest of the trainee’s training and principally serve to increase the trainee’s knowledge and to gain relevant experience.

Placement description

We are looking for a trainee in the Committees and Quality Assurance Department.

Specific objectives and projects

The Expert Panels on high-risk medical devices provide scientific opinions and views on the notified body’s Clinical Evaluation Assessment report (CECP) and the manufacturer’s consultation on the Performance Evaluation report (PECP), respectively. They support the medical device regulation by providing scientific, technical and clinical assistance to European Commission and the Medical device Coordination Group on the implementation of the regulation. More recently, the Expert Panels have increased responsibilities in the area of orphan devices, where a new procedure to support the conformity assessment has been established to help notified bodies and manufacturers with predictability in the requirement of clinical evidence in the context of limitations in pre-clinical and clinical data and to provide advice on clinical investigations and intended clinical development strategies for manufacturers. 
To help support innovation and the availability of devices for small populations, the Expert Panels secretariat would like to develop further on strategic areas of unmet medical need (e.g. pediatric devices, cardiovascular diseases, etc.) and to leverage opportunities to engage with stakeholders to improve clinical trial methodologies to help drive faster innovation and approval of devices. By bridging these efforts, the goal is to improve availability of devices that will foster better patient outcomes. 

As a trainee, you will be involved in a strategic initiative aimed at addressing the challenges posed by medical device regulation in providing advice on high risk medical devices.

Your tasks will include:

• Supporting the strategic analysis and mapping of topics for high risk medical devices and how the Expert Panels can contribute to the development of innovative pathways and strategies.
• Engaging in multi-stakeholder initiatives, collaborating with various experts and organisations.
• Coordinating and facilitating meetings from start to finish, ensuring effective communication and collaboration between key stakeholders, including experts from the panels, notified bodies, and external partners.
• Preparing key documents and reports, summarizing meeting outcomes, shaping policy and regulatory approaches to the new initiatives.

Learning outcomes

1.    In-depth understanding of regulatory processes: Gain a comprehensive understanding of the European Medicines Agency’s (EMA) approach to the support of the Expert Panels. This includes familiarity with regulatory requirements, agency processes and best practices related to CECP and PECP procedures.
2.    Multi-stakeholder communication: Develop skills in multi-stakeholder communication by liaising with scientific committees, experts and external partners. This will enhance your ability to coordinate and facilitate meetings, ensuring effective communication and collaboration.
3.    Strategic analysis and proposal development: Learn to support strategic analysis and mapping of topics for the Expert Panels within the medical device space. Contribute to the development of new initiatives aimed at addressing the strategic aims in relation to the  medical device regulation.
4.    Project coordination and documentation: Gain experience in coordinating and facilitating meetings from start to finish. Prepare key documents and reports, summarizing meeting outcomes and supporting the team with technical and regulatory aspects of the procedures.

Eligibility criteria

To be eligible for consideration for this placement, you are required to:

1. enjoy full rights as a citizen of a European Union Member State or Iceland, Lichtenstein and Norway;
2. possess a university degree in pharmacy, medicine, medical engineering or other life sciences (minimum of three years or more) that must have been obtained between 6 May 2024 and 6 May 2025 or be a university student on an Erasmus + or a similar programme or a PhD student or a Master's student with a previous fully finished degree in the areas mentioned before.
3. a thorough knowledge of English (at least level C1) and good knowledge of other official EU language (at least B2) of the Common European Framework for Languages

For criteria 1 and 2, you will be required to provide proof in the application form and at the interview stage. Failing to present these documents may result in the disqualification from the procedure.

Additional skills

• Analytical thinking: Ability to analyse complex data and information to support strategic decision-making and proposal development.
• Communication skills: Strong written and verbal communication skills, with the ability to engage effectively with various stakeholders and present information clearly.
• Team collaboration: Proven ability to work collaboratively within a team, contributing to a positive and productive work environment.
• Project management: Experience in coordinating and managing projects, ensuring timely completion of tasks and effective collaboration among team members.
• Attention to detail: High level of accuracy and attention to detail in preparing documents and reports.
• Adaptability: Flexibility to adapt to changing priorities and work effectively in a dynamic environment.

Behavioural Competencies

You will demonstrate the following behavioural competencies:

• Communication skills
• Interpersonal skills
• Working with others
• Adaptability
• Research and analytical skills
• Learning and development

Expected selection timelines

Conditions of traineeship

The traineeship is offered for 10 months (1 October 2025 – 31 July 2026) and takes place at the Agency’s premises in Amsterdam with possibility for teleworking up to 40% of working time from The Netherlands and occasional teleworking from outside The Netherlands. Traineeships are offered for either full-time or part-time (80% or 50%) if combined with university studies.

The Agency pays a monthly stipend of €1,942.19 for a full-time traineeship (reduced accordingly for 80% or 50%) and a travel contribution upon joining the Agency.

Each trainee will have a mentor at the Agency who will guide the trainee through the programme.

The conditions of employment are stated in the Executive Decision on rules governing the traineeship programme at the EMA available here.