Principal Clinical Evaluation Scientist

About the role

This is a highly dynamic role in which you will work in a team environment to develop global evidence‑based clinical strategies for interventional cardiology medical devices by creating clinical documentation that systematically synthesizes information from multiple data sources.

Key responsibilities

• Compile, appraise, and evaluate data from multiple sources including clinical trials, medical literature, design verification/validation data, and product complaint data, and develop literature search strategies.
• Create analyses to evaluate product benefit/risk profile, safety and performance, develop adverse event profiles, identify evidence gaps and propose prospective evidence strategies.
• Collaborate with leadership and cross‑functional partners to develop global clinical strategies for new product development or EU MDR certification, ensure alignment of clinical data with risk documentation, and contribute to product labeling.
• Develop and execute strategies for regulatory responses and regulatory submissions.

Required profile

• Bachelor’s degree in Health Sciences.
• 7+ years of experience in the medical device industry.
• Strong analytical skills with ability to efficiently review and synthesize medical literature.
• Experience writing clinical evaluation reports and post‑market clinical follow‑up reports.
• Experience applying principles of EU MDR and communicating with regulatory bodies.
• Strong medical/scientific writing skills.