Scientific Officer (multiple roles)

About this position:

European Medicines Agency (EMA) is recruiting Scientific and Regulatory professionals to support the work of the Agency’s Scientific Committees, Expert Panels and product evaluation activities across human medicines and medical devices.

In these positions, among other duties, you will contribute with your scientific, regulatory and procedural expertise to the evaluation and lifecycle oversight of medicinal products and medical devices in the European Union. You will coordinate committee and expert activities, manage the advice procedure for medical devices and provide regulatory intelligence to internal and external stakeholders.

Working in a highly collaborative EU regulatory environment, you will support high-quality scientific opinions, robust benefit–risk assessments, and consistent application of EU legislation, contributing directly to the protection and promotion of public and animal health.

Scientific Committee Officer: 
This role oversees the full organisational and procedural management of Committee meetings, including preparing agendas, ensuring compliance with rules and conflicts of interest policies, and producing accurate minutes and publications. It ensures effective coordination, record management, and continuous process improvement across Committees while monitoring work plans and escalating significant issues when needed. The role also provides delegated scientific, regulatory, and procedural support in pre and post-authorisation activities.
Link to the role profile to be added 

Scientific Officer (Medical Devices)
The role involves managing endtoend advice procedures for medical devices, from validating submissions and coordinating expert involvement to monitoring timelines and ensuring highquality panel outputs. It also covers governance and operational support for the Medical Device Expert Panels, including preparing procedural documents, organising expert selection, training, and meetings. Additionally, the role ensures regulatory implementation, consistency across panels, publication of opinions, and responses to internal and external queries.
matching your skills, competencies and experience.

Scientific Officer (Product Lead)
The product lead role, leads the scientific and regulatory evaluation and post-license oversight of human medicines by leading the wider EMA product team and liaising closely with Rapporteurs and their assessment teams. Each product lead manages a product portfolio, drives benefit–risk assessments, coordinates product teams, and act as primary point of contact for applicants and Rapporteurs. The role also includes close collaboration with working parties and coordination of drafting groups works on scientific guidelines, as well as scientific and regulatory exchanges with third party regulators via the EMA clusters.

Regulatory Affairs Officer
This role provides expert regulatory advice across the Agency, supporting scientific committees and working groups on topics such as paediatrics, orphan designation, scientific advice, and safety. It involves developing regulatory and procedural guidance, ensuring compliance with EU legislation for an assigned portfolio of medicinal products, and supporting the implementation of new pharmaceutical laws. The role also coordinates with the European Commission and EMA’s legal department to ensure coherent and robust regulatory positions.

Here are the links to the Role Descriptions, outlining generic duties and responsibilities:

Scientific Committee Officer :https://www.ema.europa.eu/en/documents/other/role-description-scientific-committee-officer_en.pdf

Scientific Officer (Medical Devices/Product Lead):  https://www.ema.europa.eu/en/documents/recruitment/role-description-scientific-officer-fgiv_en.pdf

Regulatory Affairs Officer: https://www.ema.europa.eu/en/documents/other/role-description-regulatory-affairs-officer_en.pdf

Apply if you meet these eligibility criteria:

General Conditions: 
1.    Enjoy full rights as a citizen of a European Union Member State or Iceland, Lichtenstein and Norway;
2.    A thorough knowledge of English (at least level C1) and a satisfactory knowledge of another official language of the European Union (at least level B2);
3.    Have fulfilled any obligations imposed by applicable laws concerning military service.

Specific Conditions:
1. Possess a university degree of a minimum of three years in Medicine or Life Science (e.g. biology, chemistry, biochemistry, pharmacy, pharmachology or other relevant life science degree) that must have been obtained by the closing date of this vacancy notice.

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General Condition 1 and Specific Conditions 1 will be verified firstly based on the application form and then you will be required to provide documentary evidence at the interview stage. Failing to present these documents may result in the disqualification from the selection procedure.

Only candidates eligible will be assessed by the Selection Committee in accordance with the Assessment Criteria below.

You will also need to have:

Experience

• Experience in managing a wide range of stakeholders in the pharmaceutical and/or medical devices areas;
• Experience with development or evaluation of medicinal products and/or medical devices related work;
• Experience in drafting or assessing regulatory and scientific documents/reports requiring attention to detail and pharmaceutical and/or medical devices development knowledge;
• Experience in medicines and/or medical devices development or regulation—gained in a competent authority, pharmaceutical or medical devices industry, or healthcare/academic setting—must cover scientific, regulatory, or procedural aspects of researching, developing, authorising, producing, or supervising human medicines or medical devices. Within this experience, you must have at least two years of professional experience in one of the following, depending on the profile applied for:

• • Scientific Committees Officer:  experience  in the field of EU medicines regulation and/or in the management of scientific/regulatory meetings
  • Scientific Officer (Medical Devices): experience in the medical device sector (e.g.: manufacturer, consultancy, notified body, or competent authority).
  • Scientific Officer (Product Lead): experience preparing or assessing documentation for clinical trials, marketing authorisations, or lifecycle management of human medicines.
  • Regulatory Affairs Officer: experience in regulatory affairs in the pharmaceutical setting 

Skills & Knowledge

•    Planning and organisational skills; 
•    Good scientific and regulatory technical skills, including knowledge of EU medicines and/or medical devices framework, gained through experience;
•    Critical review and drafting of scientific and regulatory documents for experts and lay audiences;
•    Presenting scientific, or regulatory matters at a high level (including experts);
•     Good understanding of the Centralised procedure and the role of EMA and its Scientific committees;
•    Excellent attention to detail;
•    Ability to handle high workload effectively and to deliver high quality results under situations of time constraints or pressure standards; 
•    Basic knowledge of clinical development of medicines and/or medical devices in one or more therapeutic areas.

Competencies you will need to have:

Sub-family competencies 

• Regulatory frameworks & strategy, Basic 
• Applied knowledge, Basic 

Grade competencies 

• Adaptability and agility, Intermediate 
• Coping with pressures and setbacks, Intermediate 
• Analysing and problem solving, Intermediate 

Core competencies 

• Ethics and integrity, Intermediate 
• Team collaboration, Intermediate 
• Customer centricity, Intermediate 
• Results orientation, Intermediate 
• Communication, Intermediate 
• Cross-cultural sensitivity, Intermediate 
• Continuous learning and self-development, Basic 

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For more information about definitions of competencies and associated proficiency levels, please refer to the EMA Competency Framework.

These are considered nice to have:

Education
Masters in a relevant field of study (Medicine or Life sciences, as above);

Experience: 

• Four or more years of experience in the regulation of human medicines and/or medical devices through EU-wide or national regulatory procedures, gained within a competent authority, a notified body, the pharmaceutical or medical devices industry, healthcare, consultancy, or academic settings. 
• Experience in regulatory or scientific information analysis, preparation of documentation or reports, and the ability to collaborate in complex, cross functional environments. 
• Proven ability to interact effectively with internal and external stakeholders—including in multinational contexts

1. Scientific Committee Officer
•    Ability to organise scientific or regulatory meetings (e.g., committees, drafting groups).

2. Scientific Officer (Medical Devices)
•    Regulatory experience covering both medicines and medical devices.
•    Background in life cycle management, coordination of regulatory procedures, and/or mecical device regulatory frameworks.

3. Scientific Officer (Product Lead)
•    Five years of experience with centralised or national procedures for human medicines.
•    Five years expertise in scientific/regulatory information analysis and reporting.
•    Clinical experience in a therapeutic field.
•    Nonclinical experience in a GLP laboratory 
•    Deep understanding of regulatory standards affecting medicines development and authorisation.

4. Regulatory Affairs Officer
•    Experience in providing regulatory advice obtained in competent authorities, industry, consultancy, or healthcare settings.
•    Experience working with international stakeholders in a complex regulatory environment.

Certificates
Master’s degree or post-graduate degree or any relevant certificate  in regulatory affairs and/or science.