Clinical Scientist
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Job Location:
Newark, DE - USA
Monthly Salary:
Not Disclosed
Posted on:
8 hours ago
Vacancies:
1 Vacancy
Job Summary
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.
- 58 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:
- 24 years of CER writing experience in the medical device industry.
- Knowledge of EU MDR and clinical evaluation processes.
Additional Information :
All your information will be kept confidential according to EEO guidelines.
Remote Work :
No
Employment Type :
Contract
Key Skills
- Laboratory Experience
- Immunoassays
- Machine Learning
- Biochemistry
- Assays
- Research Experience
- Spectroscopy
- Research & Development
- cGMP
- Cell Culture
- Molecular Biology
- Data Analysis Skills
About Company
At Fusion Plus Solutions Inc, we believe that it’s an exceptional company - a company of people proud of the work they do and the solutions they provide. By understanding what drives our specialty industries, becoming involved in our communities on a professional and personal basis, f ... View more
