Clinical Evaluation Specialist

• Knowledge of MEDDEV 2.7/1 Rev. 4 and relevant MDCG guidance.
• Familiarity with ISO 14155 and clinical investigations of medical devices.
• Experience with Ethics Committee or Competent Authority submissions.
• Experience with statistical analysis of clinical study data.
• Knowledge of Class IIa or Class IIb medical devices.
• Interest in rehabilitation technologies, robotics or neurorehabilitation.

We are looking for a Clinical Evaluation Specialist to join our Clinical and Regulatory team and support the generation and maintenance of clinical evidence for our medical devices.

The main focus of the position will be Clinical Evaluation activities under the EU Medical Device Regulation (MDR), including the preparation and maintenance of Clinical Evaluation Plans (CEP), Clinical Evaluation Reports (CER), literature reviews and related clinical documentation.

The role will work closely with senior Clinical and Regulatory team members and will progressively develop greater autonomy in Clinical Evaluation activities.

Clinical Evidence:

• Support the preparation and maintenance of CEP & CER in accordance with MDR.
• Perform structured literature searches and critically appraise scientific/clinical evidence.
• Support the assessment of clinical data from literature, clinical investigations, PMCF, PMS and other post-market sources.
• Contribute to State-of-the-Art assessments, treatment alternatives and similar medical devices.
• Ensure consistency between clinical evidence, intended purpose, product claims, risk management and Technical Documentation.
• Support responses to Notified Body questions related to Clinical Evaluation and clinical evidence.
• Keep up to date with relevant MDR requirements, MDCG guidance and applicable standards.
• Occasionally support the review of PMCF, PMS and post-market clinical data.

Provide occasional support to ongoing clinical investigations, including:

• Preparation of study reports and clinical evidence summaries.
• Preparation and maintenance of study documentation.
• Submissions to Ethics Committees and Competent Authorities.
• Coordination with investigators and participating centres.
• Review, cleaning and analysis of clinical study data.

Location: Barcelona, Spain (immediate incorporation)

Employment type: Full-time, permanent contract

Working model: Hybrid, up to 2 remote-working days per week

• Bachelor's or Master's degree in Biomedical Engineering, Biomedical Sciences, Life Sciences, Health Sciences or a related scientific or engineering discipline.
• 1-2 years of experience with medical devices, Clinical Affairs, Regulatory Affairs, clinical research or a related field.
• Previous exposure to Clinical Evaluation activities, CERs, CEPs and/or systematic or structured literature reviews.
• Basic understanding of Clinical Evaluation under MDR.
• Strong analytical, scientific writing and critical appraisal skills.
• Ability to work effectively with multidisciplinary teams.
• High attention to detail and good organisational skills.
• Good communication skills in English and Spanish.