JOB DESCRIPTION

Project leader – Assessor

Directorate-General for Health and Food Safety (DG SANTE)
of the European Commission

Selection reference: SANTE/COM/2025/2091
Domain: Audit
Where: Unit F5 – Health Protection, Grange, IRELAND
Staff category and Function Group: Temporary agent 2b – Administrator
Grade range: AD5-7
Publication deadline: 04.11.2025 – 12.00 (Midday, Brussels time)

WE ARE

The Directorate-General for Health and Food Safety (DG SANTE) aims to give Europeans the peace
of mind that comes with access to healthcare, safe food and protection against epidemics and
diseases. Our goal is to build and maintain Europe’s high standards on food and feed safety, food
sustainability, animal and plant health, and deliver the most affordable, accessible and high-quality
health systems.

Unit SANTE.F5 – Health Protection is one of the units in Directorate F (Health and Food Audits and
Analysis) of DG SANTE. The Directorate is based in Grange, Co. Meath, Ireland.

The unit is responsible for carrying out, in the area of Health Protection, joint assessments, audits
and other tasks concerning the control and monitoring of the applicable standards. The
responsibilities of the unit cover medical devices, antimicrobial resistance, active pharmaceutical
ingredients for human use, clinical trials for human medicines and veterinary medicinal products.

The implementation of Regulation (EU) 2017/745 on medical devices and Regulation (EU)
2017/746 on in-vitro diagnostic medical devices is a key priority for the European Commission and
Member States, and joint assessments are a legal obligation under these Regulations. The goal of
joint assessments is to contribute to ensuring that only appropriately resourced and adequately
performing notified bodies certify medical devices and in-vitro diagnostic medical devices.

Each joint assessment is carried out by the concerned national authority together with a joint
assessment team composed by Commission experts/auditors and, at least, two national experts. An
on-site assessment is part of the overall assessment process of: i) conformity assessments bodies,
in the context of their designation, and ii) notified bodies, in the context of their re-assessment and
extension of their scope of designation.

WE PROPOSE

A post of project leader in Unit F5.

The jobholder’s main task is to lead the organisation of joint assessments in the field of medical
devices and in-vitro diagnostic medical devices. Such a task involves coordinating and overseeing
the corresponding outputs produced by the different joint assessment teams, as well as promoting
the availability and organising the participation of Member States’ experts.

In addition, the project leader should also take the lead in the organisation of other related
activities of the medical devices team, notably the liaison with the corresponding policy unit and
the organisation of training for Member States’ experts.

Lastly, the project leader is expected to contribute to the management of other areas covered by
the unit, on a needs basis.

WE LOOK FOR

1. A colleague to coordinate the organisation and execution of joint assessments of conformity
assessment/notified bodies in the area of medical devices, and other related activities. The
successful candidate should therefore be a graduate in a discipline such as bio-medical
engineering, medicine, pharmacy, bio-medical sciences, veterinary science, or equivalent.

2. At least 3 years of professional experience working in the area of medical devices are
absolutely essential for the successful candidate. That experience must refer, at least for 2
years, to the execution of joint assessments, including, preferably, the coordination of joint
assessment teams.

3. The successful candidate could have gathered the above experience at different levels, for
instance, working in a national/international authority/regulator, in an authority responsible for
notified bodies, or in a conformity assessment/notified body.

4. The successful candidate must possess a comprehensive knowledge of the EU legislative
framework governing the area of medical devices, and also a thorough knowledge of the
framework pertaining to joint assessments.

5. The successful candidate must have at least 1 year of experience managing teams, and has to

be a resilient individual with very strong soft skills.

6. The successful candidate must be a committed and motivated individual, with a strong capacity
for teamwork and the flexibility necessary to deal with unexpected tasks. In addition, she/he
must have strong interpersonal and negotiation skills, as the job involves (on top of managing
an internal team within the Commission) liaising with national experts participating in joint
assessments. Per year, the jobholder is expected to participate in up to 10 in-person
meetings/fora with national authorities and/or stakeholders, in the context of the joint
assessment process. Moreover, she/he could be required to participate (on a needs basis) in up
to 2-3 on-site assessments.

7. The successful candidate should have demonstrable analytical and technical skills to correlate

and compare information from different sources.

HOW TO EXPRESS YOUR INTEREST?

You should send your documents in a single pdf in the following order:
1. your CV
2. completed application form.

send

these

SANTE-HR-
the
Please
[email protected] indicating the selection reference SANTE/COM/2025/2091 in the
subject.

documents

publication

deadline

by

to

No applications will be accepted after the publication deadline.

ANNEX

You must meet the following eligibility criteria when you validate your application:

Our rules provide that you can only be recruited as a temporary agent at the European Commission if you:

General criteria:

• Are a citizen of a Member State of the EU and enjoy full rights as a citizen
• Have fulfilled any obligations imposed by applicable laws concerning military service
• Are physically fit to perform the duties linked to the post
• Produce the appropriate character references as to suitability for the performance of the duties.

Qualifications:
In order to be recruited for this position, you must have at least a level of education which
corresponds to completed university studies of at least 3 years attested by a diploma.

Only qualifications issued or recognised as equivalent by EU Member State authorities (e.g. by the
Ministry of Education) will be accepted. Furthermore, before recruitment, you will be required to
provide the documents that corroborate the eligibility criteria (diplomas, certificates and other
supporting documents).

Languages:
•

have a thorough knowledge (minimum level C1) of one of the 24 official languages of the
EU2

• AND a satisfactory knowledge (minimum level B2) of a second official language of the EU,

to the extent necessary for the performance of the duties.

➢ What about the selection steps?

The post was published internally within the Commission, inter-institutionally, and brought to the
attention of competition laureates.

2 The official languages of the European Union are: BG (Bulgarian), CS (Czech), DA (Danish), DE (German), EL
(Greek), EN (English), ES (Spanish), ET (Estonian), FI (Finnish), FR (French), GA (Irish), HR (Croatian), HU
(Hungarian), IT (Italian), LT (Lithuanian), LV (Latvian), MT (Maltese), NL (Dutch), PL (Polish), PT (Portuguese), RO
(Romanian), SK (Slovak), SL (Slovenian), SV (Swedish).