Clinical Development Specialist

Clinical Development Specialist
Location: Eindhoven
Duration:12 months (with possibility of extension)

About the Company

Our client is a global leader in healthcare technology, dedicated to improving lives through innovative medical solutions. They focus on pioneering advancements in clinical development, ensuring the safety and effectiveness of cutting-edge medical products.

About the Role

We are seeking a Clinical Development Specialist to drive benefit-risk analysis, risk management, and clinical evidence generation for medical devices. In this role, you will collaborate with multidisciplinary teams to support regulatory approvals and post-market surveillance while contributing to life-changing healthcare innovations.

Responsibilities

• Conduct benefit-risk analyses and lead clinical risk assessments.
• Collect, appraise, and analyze clinical data for medical products.
• Develop and write clinical documentation, including Clinical Evaluation Reports (CERs) and Post-Market Clinical Follow-up Reports (PMCF).
• Support clinical trials and regulatory submissions in the USA, EU, and other regions.
• Collaborate with internal and external stakeholders to ensure regulatory compliance and effective clinical evidence dissemination.

• M.D., Master’s, or Ph.D. in Biomedical Science or a related field, with 3–5 years of experience in the medical device or pharmaceutical industry.
• Expertise in benefit-risk analysis, clinical risk management, and vigilance reporting.
• Strong medical writing skills and experience with MDR-compliant CERs and PMCFs.
• Knowledge of GCP, ICH guidelines, ISO14155, FDA, and EU regulations.
• Experience in clinical investigations, biostatistics, and research methodology.
• Excellent collaboration and communication skills in English.

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