PhD Position Decision-making Under Uncertainty for Emerging Orphan and Breakthrough Medical Devices

Delft University of Technology (TU Delft); Delft; On-site; EUR 36,000 - 45,000; Full time

Benefits offered by this job

Customisable compensation package

Health insurance discounts

Monthly work costs contribution

Job summary

Delft University of Technology (TU Delft) invites applications for a four‑year PhD project on acceptable uncertainty in clinical evidence for regulatory decisions regarding orphan or breakthrough medical devices. The work is part of the COMPASS4MD consortium and combines regulatory research with empirical studies across Europe.

You will review regulatory documents, conduct interviews with regulators and industry, and develop practical recommendations for post‑market evidence and sandbox

Qualifications

• Master’s degree in health, policy, governance, or related field.
• Excellent command of English; Dutch is a plus.
• Experience connecting biomedical questions with policy, governance, or stakeholder perspectives.

Responsibilities

• Study how uncertainty is described and assessed in regulatory practice.
• Review regulatory documents and opinions across Europe and conduct expert interviews.
• Develop realistic case scenarios and discuss with patients, clinicians, and regulators.
• Propose practical regulatory approaches, including post‑market evidence and sandboxes.

Skills

Excellent communication

Collaboration across disciplines

Organisational skills

Research experience

English proficiency

Education

Master’s degree in Health Sciences or related field

Job description

What uncertainty in clinical evidence is acceptable for regulatory actors and patients to allow orphan or breakthrough devices on the market, while also ensuring these devices are sufficiently safe?

Job description

Innovative medical devices can offer important benefits to patients, especially when existing diagnostic or treatment options are limited. At the same time, the available clinical evidence may be limited or contain uncertainties when a device is assessed for market access. Regulators and notified bodies therefore need to decide when evidence is sufficient, what uncertainties can be considered acceptable, and under what conditions additional evidence should be collected after a device enters the market.

In this PhD project, which is part of the European COMPASS4MD project, you will study how these decisions are currently made in practice, and how uncertainty could be managed in the future. You will explore how uncertainty in clinical evidence is described and assessed, which factors make uncertainty more or less acceptable, and how unmet medical needs, small patient populations and expected patient benefits influence regulatory decisions. Building on these insights, you will examine how future regulatory approaches could support more responsible decision-making under uncertainty.

The research combines several methods. You will review regulatory documents and publicly available regulatory opinions from across Europe (and potentially other jurisdictions). You will also interview professionals involved in the assessment of medical devices, such as notified‑body assessors, regulators, and Expert Panel members. Based on these findings, you will develop realistic case scenarios that present different types and levels of uncertainty. These scenarios will be discussed with patients, clinicians, manufacturers, regulators, notified bodies, and health technology assessment bodies to explore where their views overlap and where they differ.

The final part of the project focuses on how regulation can deal with uncertainty in a responsible way. A particular area of interest is the use of regulatory sandboxes: controlled environments in which regulators, developers, and other stakeholders can explore regulatory questions and test approaches to evidence generation while a technology is still developing. You will also consider related approaches, including conditional market access and post‑market evidence generation. The aim is to develop practical recommendations that support access to promising medical technologies while continuing to protect patients.

This PhD project is part of the European COMPASS4MD consortium and will involve close collaboration with research institutes, regulators, clinical experts, patient representatives, and other partners across Europe. You will contribute to joint project activities, exchange findings with partners from different countries and disciplines, and help organise interviews and stakeholder workshops. The position therefore suits someone who communicates easily, enjoys working with people from different countries and disciplines, and is willing to take an active role in an international consortium. You should be comfortable working independently on your own research while also contributing to shared activities, meetings, workshops, and deliverables with European project partners. Some travel within Europe may be part of the position.

English proficiency is required. Proficiency in Dutch is considered an advantage, but is not a requirement. Experience with medical‑device regulation, clinical research, benefit–risk assessment, stakeholder workshops, survey experiments, or anticipatory governance is an advantage. We do not expect candidates to already possess expertise in all these areas; we particularly value the ability and motivation to work across disciplinary boundaries.

Job requirements

• Master’s degree in a relevant field, such as Health Sciences, (Technical) Medicine, Health Policy or Healthcare Management, Public Policy, Innovation Sciences, Management of Technology or Technology Governance, Biomedical Engineering or a related field. As the project combines the analysis of clinical evidence with empirical research into regulatory decision-making, we particularly welcome candidates who can connect biomedical or clinical questions with policy, governance, and stakeholder perspectives.
• Excellent communication and collaboration skills.
• Good organisational skills.
• Research experience and writing skills demonstrated through a thesis, publications, or previous research projects.
• Excellent command of English is required. Dutch is considered an advantage.

TU Delft (Delft University of Technology)

Working at TU Delft means contributing to solutions that really make a difference.

For over 180 years, we have been training engineers who make an impact worldwide in companies, government bodies, or as entrepreneurs. Our alumni turn knowledge into concrete solutions for the challenges of today and tomorrow. These challenges are changing rapidly. That is why we focus on themes such as energy, climate, digitalisation, artificial intelligence (AI), and smart mobility every day. Our education and research are directly aligned with what society needs now and in the future.

At TU Delft, our people make the difference. With their knowledge and curiosity, our staff provide a high‑quality education and conduct pioneering research that extends beyond the campus. You will have the opportunity to take the initiative, work with others, and grow as a professional. Working at TU Delft means join an international community of professionals and students. Together, we create knowledge, innovations, and solutions that help move the world forward.

Faculty Technology, Policy & Management

The Faculty of TPM provides an important contribution to solving complex technical‑social issues, such as energy transition, mobility, digitalisation, water management and (cyber) security. TPM does this with its excellent education and research at the intersection of technology, society and policy. We combine insights from both engineering and social sciences as well as the humanities. TPM develops robust models and designs, is internationally oriented and has an extensive network of knowledge institutions, companies, social organisations and governments.

Click here to go to the website of the Faculty of Technology, Policy and Management.

Conditions of employment

Doctoral candidates will be offered a 4-year period of employment in principle, but in the form of 2 employment contracts. An initial 1,5 year contract with an official go/no go progress assessment within 15 months. Followed by an additional contract for the remaining 2,5 years assuming everything goes well and performance requirements are met.

Salary and benefits are in accordance with the Collective Labour Agreement for Dutch Universities, increasing from €3204 - €4051 gross per month, from the first year to the fourth year based on a fulltime contract (38 hours), plus 8% holiday allowance and an end‑of‑year bonus of 8.3%.

As a PhD candidate you will be enrolled in the TU Delft Graduate School. The TU Delft Graduate School provides an inspiring research environment with an excellent team of supervisors, academic staff and a mentor. The Doctoral Education Programme is aimed at developing your transferable, discipline‑related and research skills.

The TU Delft offers a customisable compensation package, discounts on health insurance, and a monthly work costs contribution. Flexible work schedules can be arranged.

Will you need to relocate to the Netherlands for this job? TU Delft is committed to make your move as smooth as possible! The HR unit, Coming to Delft Service, offers information on their website to help you prepare your relocation. In addition, Coming to Delft Service organises events to help you settle in the Netherlands, and expand your (social) network in Delft. A Dual Career Programme is available, to support your accompanying partner with their job search in the Netherlands.

Additional information

If you would like more information about this vacancy or the selection procedure, please contact dr.ir. Britte Bouchaut, via [e-mail].

• #EUfunded This is an EU funded project, named COMPASS4MD, with project number 101343766, within program Horizon Europe
• As part of knowledge security, TU Delft conducts a risk assessment during the recruitment of personnel. We do this, among other things, to prevent the unwanted transfer of sensitive knowledge and technology. The assessment is based on information provided by the candidates themselves, such as their motivation letter and CV, and takes place at the final stages of the selection process. When the outcome of the assessment is negative, the candidate will be informed. The processing of personal data in the context of the risk assessment is carried out on the legal basis of the GDPR: performing a public task in the public interest. You can find more information about this assessment on our website aboutknowledge security.