Clinical Specialist > Lille > Joboolo FR :

A global leader in the sports medicine market and experiencing strong growth, we offer innovative solutions based on cutting-edge technologies.


As part of our development, we are recruiting a Clinical Affairs Specialist (M/F).

Reporting to the R&D – Clinical Affairs Department, your main responsibilities will include:

Scientific and Competitive Intelligence

• Research, analysis, synthesis, and monitoring of clinical and scientific literature related to the company’s products


• Research on techniques, safety, efficacy, and performance of competitors’ products


• Maintenance of the bibliographic database and analysis of new clinical data

Clinical Safety Documentation

• Drafting of Clinical Evaluation Reports (CER) in accordance with MEDDEV 2.7/1


• Implementation and execution of PMCF (Post-Market Clinical Follow-up) studies


• Support for Post-Market Surveillance (PMS) activities

Clinical Studies

• Drafting documentation related to clinical studies


• Development of protocols to monitor product performance and safety in a clinical context


• Drafting follow-up questionnaires


• Analysis of results


• Collaboration with CROs


• Management of clinical studies

Regulatory Affairs

• Support the Regulatory Affairs team in product registration processes in Europe and internationally


• Assist in drafting Clinical Evaluation Reports (CER) and Clinical Development Plans (CDP), among others

Profile Sought

• Biomedical engineer or graduate in Health Sciences or a biomedical-related field


• Minimum 5 years of experience in clinical and regulatory affairs related to medical devices, ideally diagnostic support software for medical imaging


• Experience in setting up and drafting documents such as CEP, CER, PMCF, PSUR, etc.


• Knowledge of medical device regulations and standards (MDD/MDR, ISO 14971, ISO 13485)


• Experience drafting CERs in accordance with MEDDEV 2.7/1


• Experience with English-language literature searches, analysis, and synthesis


• Excellent professional English level, particularly in writing

Dynamic and proactive, you demonstrate strong interpersonal skills, autonomy, and rigor.


You are curious, possess excellent writing skills, and have a strong sense of results and synthesis.


You have a keen interest in medical devices, particularly in orthopedics and sports medicine.