Medical Devices Senior Scientific Specialist

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).

About this position

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.

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.

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

1. 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.

Requirements

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 (e.g. to experts).

Competencies

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

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.

What we offer

• Meaningful work contributing to protecting the health of every individual and animal in Europe within multinational, multidisciplinary team
• Development opportunities (e.g. internal mobility, mentoring, peer coaching, career reflection programme, etc.)
• Work-life balance (flexible working arrangements, teleworking, generous annual leave plus official holidays)

Benefits (applicable only to Temporary and Contract vacancies)

• Initial 5 year contract with competitive monthly tax-free salary and household & children’s allowances (where applicable)
• Privileges for expatriate staff including expatriation and education allowances (where appropriate) and additional home leave
• Relocation assistance
• Excellent health insurance scheme and social benefits
• Retirement Pension Plan

Conditions of employment

In principle, the Agency offers a five-year renewable contract. Contracts of a shorter duration may be offered to the candidates. The successful candidate(s) will be required to relocate to the Netherlands to pick up duties.