Medical Devices Senior Scientific Specialist

About this position:

Human Medicines Division, Committees and Quality Assurance Department, Expert Panels and Groups Office (H-QA-EPG) is looking for a Medical Devices Senior Scientific Specialist to play a pivotal role providing scientific secretarial support to the medical devices’ expert panels in the evaluation and advice on high-risk medical devices and in vitro diagnostics (IVDs). Your work will directly influence clinical evaluations of high-risk devices and performance evaluation IVD driving innovation and patient safety across Europe.

In this role, you will have the opportunity to lead coordination of scientific discussions, provide regulatory guidance and procedural expertise in clinical development and evaluation of high-risk medical devices and IVDs, as described in the medical device regulations (MDR/IVDR) and the extended mandate of the European Medicine Agency (EMA).

In this job you will:

• Provide scientific coordination and regulatory and/or procedural support in the areas of clinical development and evaluation of high-risk medical devices and IVDs;
• Manage the requests addressed to the expert panels, namely:
  - Clinical Evaluation Consultation Procedure,
  - Performance Evaluation Consultation Procedure, 
  - Advice to manufacturers on their proposals for clinical investigations and/or clinical development strategy,
  - Orphan device status and clinical development. 

Here is the link to the Role Description of Senior Scientific Specialist outlining generic duties and responsibilities:

https://www.ema.europa.eu/en/documents/recruitment/role-description-scientific-senior-specialist-ad8_en.pdf

Apply if you meet these eligibility criteria:

To be eligible for consideration for this position, you are required to meet the following general and specific eligibility conditions: 

General conditions: 
1.    enjoy full rights as a citizen of a European Union Member State, Iceland, Liechtenstein or Norway; 
2.    have 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. 

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Specific conditions: 

1.    possess a university degree (minimum of four years) in  the field of Biomedical Sciences (e.g. biology, chemistry, biochemistry, medicine, biomedical engineering) that must have been obtained by the closing date of this vacancy notice, and at least 9 years’ relevant professional experience after obtaining the relevant degree, that must have been obtained by the closing date, in the field of the above-mentioned areas and duties. 

or

2.   possess a university degree (minimum of three years) in the field of Biomedical Sciences (e.g. biology, chemistry, biochemistry, medicine, biomedical engineering) that must have been obtained by the closing date of this vacancy notice, and at least 10 years’ relevant professional experience after obtaining the relevant degree, that must have been obtained by the closing date, in the field of the above-mentioned areas and duties.  

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General Condition 1 and Specific Conditions 1 and 2 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.

You will also need to have:

Experience

• at least 9 years of demonstrated working experience in clinical development, assessment and/or regulation of medical devices, in in vitro diagnostics or high-risk medical devices 

Skills & Knowledge

• Excellent general knowledge of the EU medical device and in vitro medical device regulations (MDR and IVDR) and the regulatory framework of medical devices in the European Union, including standards and Medical Devices Coordination Group (MDCG) guidelines relevant to the role;
• Knowledge and understanding of relevant related current legislation and guidance and ability to interpret and advise on their application;
• Knowledge of general methodology for medical device development and/or assessment.
• Basic knowledge of critical review and drafting of scientific and regulatory documents for expert and lay audiences;
• Basic knowledge and understanding of the EU pharmaceutical legislation and the regulatory framework for pharmaceutical products in the EU, including ICH guidelines relevant to the role;
• Presenting scientific, or regulatory matters at a high level (eg to experts).

Competencies you will need to have:

Role competencies 

• Scientific evidence management – Intermediate
• Scientific product lifecycle and procedure management - Intermediate  
• Influencing and persuading – Advanced
• Prioritising and organising – Advanced 

Sub-family competencies 

• Regulatory Framework and Strategy - Advanced
• Applied knowledge - Advanced 

Grade competencies

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

Core competencies 

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

The assessment of competencies forms an important part of this selection process. EMA therefore advises you to refer to its Competency Framework for more information on the definitions of these competencies and their associated levels.

These are considered nice to have:

Experience

• In analysing and writing on scientific/regulatory matters: information analysis and reporting on scientific/ regulatory matters;
• In researching, analysing and presenting scientific data including scientific or medical writing;
• In working in medicines development and /or assessment. 

Skills & Knowledge

• Knowledge about converging technologies at the interface between medicines, medical devices and borderline products. 
• Knowledge of legal, regulatory and procedural aspects of EU Medicines Regulatory framework.
• Knowledge of general methodology for quality, non-clinical or clinical development;
• Knowledge of trends and innovative technologies in high-risk medical devices, in vitro diagnostics or devices used in combination with medicinal products;
• Knowledge of analytical methods and applied research skills.