You drive clinical risk management and benefit-risk analysis that directly impact patient safety worldwide. In this role, you translate complex clinical data into clear, compliant evidence that supports innovative medical technologies. You work at the intersection of science, regulation, and product development, influencing decisions from concept to market. If you want real responsibility, regulatory depth, and visible impact, this role delivers.

Description

• Lead benefit-risk assessments and clinical risk management activities throughout the full product lifecycle.
• Collect, appraise, and analyze clinical data and ensure robust clinical evidence for medical products.
• Author and maintain clinical documentation, including Clinical Evaluation Reports (CERs), Post-Market Clinical Follow-up (PMCF) Reports, and Clinical Study Reports (CSRs).
• Collaborate with multidisciplinary internal teams (regulatory, risk management, statistics, post-market surveillance) and external stakeholders to ensure compliant and high-quality clinical evidence.
• Support clinical investigations, regulatory submissions, and product approvals in the US, EU, and other regions.
• Optimize workflows, SOPs, and documentation processes within Clinical Development.

Profile

• A PHD or Master's degree in Life Sciences, Biomedical Sciences, or a related health field.
• Minimum 2 years of relevant experience in Clinical Research, MedTech, Healthcare, or a related field
• Experience with clinical documentation such as CERs, PMCFs, or CSRs is preferred.
• Knowledge of GCP, ICH guidelines, ISO 14155, FDA regulations, and EU MDR.
• Experience in benefit-risk analysis, clinical risk management, or vigilance reporting is a strong advantage.
• Affinity with clinical investigation design, research methodology, and biostatistics.
• Professional proficiency in English, both written and spoken.

Job Offer

• A salary up to € 5.500, - gross per month (excluding 8% holiday allowance).
• Travel allowance.
• 26 holidays, with options to expand.
• Flexibility and hybrid working options where applicable.
• Extensive training and career development opportunities.
• A solid pension scheme and collective health insurance.
• Discounts on sports and cultural activities.

About Brunel

Brunel Engineering connects highly skilled specialists to challenging projects within innovative industries such as Life Sciences, High Tech, and Engineering. We offer a professional, open, and performance-driven work culture where initiative is recognized.