Clinical Specialist

Barrington James; Strasbourg; Sur place; EUR 60 000 - 80 000; Plein temps

Résumé du poste

A global leader in sports medicine is seeking a Clinical Affairs Specialist to research and monitor clinical literature, manage clinical studies, and support regulatory affairs. The ideal candidate will have a degree in Biomedical Engineering or related fields, with a minimum of 5 years' experience in medical device clinical affairs. Strong analytical skills, experience with clinical documentation, and excellent English proficiency are required. This position is based in Strasbourg, France, and welcomes those passionate about medical devices and sports medicine.

Qualifications

• Minimum 5 years of experience in clinical affairs related to medical devices.
• Experience with clinical evaluation reports and regulatory submissions.
• Excellent command of written English.

Responsabilités

• Research and monitor clinical and scientific literature.
• Draft Clinical Evaluation Reports and support PMCF studies.
• Manage clinical studies and collaborate with CROs.

Connaissances

Research and analysis

Clinical documentation drafting

Knowledge of medical device regulations

Interpersonal skills

Formation

Biomedical engineer or related degree

Description du poste

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.