Job Description
Job Title: Clinical Scientist – Medical Devices
Location: Newark, DE
Long Term Contract
Role:
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:
- 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.
Required Qualifications:
- 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.
Preferred:
- 2–4 years of CER writing experience in the medical device industry.
- Knowledge of EU MDR and clinical evaluation processes.