Clinical Scientist

Clinical Scientist responsible for developing Clinical Evaluation Plans (CEP) and Clinical Evaluation Reports (CER) to support CE Mark regulatory submissions for medical devices. Key responsibilities include conducting systematic literature reviews, collaborating with R&D and Regulatory Affairs teams, and preparing clinical documentation.

Requirements

• Develop and author CEP and CER for regulatory submissions.
• Conduct systematic literature reviews and analyze clinical data for device safety and performance.
• Collaborate with R&D, Engineering, Regulatory Affairs, and Post-Market teams to support clinical strategy.
• Prepare clinical documentation such as Investigator Brochures, Clinical Study Protocols, and Clinical Study Reports (CSR).
• Respond to regulatory authority questions related to clinical evidence.
• Review risk documentation and product labeling based on clinical data.
• Manage clinical documentation timelines and ensure compliance with EU MDR, GCP, and corporate SOPs.

Benefits

• Health Insurance
• Dental Insurance
• Vision Insurance
• Life Insurance
• 401k Matching
• Paid Time Off