Clinical Scientist

Techtrueup • Newark, DE

5d

About The Position

Clinical Scientist responsible for developing Clinical Evaluation Plans (CEP) and Clinical Evaluation Reports (CER) to support CE Mark regulatory submissions for medical devices.

Requirements

• MD, PhD, or MS in a scientific field.
• 5–8 years of medical writing or clinical evaluation experience.
• Experience in CER/CEP writing, literature review, and regulatory documentation.
• Strong analytical, technical writing, and cross-functional collaboration skills.

Nice To Haves

• 2–4 years of CER writing experience in the medical device industry.
• Knowledge of EU MDR and clinical evaluation processes.

Responsibilities

• 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.

What This Job Offers

• Career Level: Mid Level
• Education Level: Ph.D. or professional degree
• Number of Employees: 1-10 employees