What are the responsibilities and job description for the Clinical Scientist position at Techtrueup?
Company Description
Fusion Life Sciences Technologies (www.fusionlifesolutions.com ) is a WBE-certified Healthcare Staffing and Engineering Services provider supporting industries including Pharma, Medical Devices, Aeronautical, Supply Chain, Heavy/Light Industrial, Food & Beverage, and Automotive. We proudly partner with 120 clients such as Johnson & Johnson, Haemonetics, Delta, Caterpillar, Artisan Chef, Baxter, and many more. Our wide network of consultants and contract-to-hire engineers brings deep expertise across Engineering, Technical, Administrative, Healthcare, Life Sciences, Blue Collar, Skilled Trades, IT, Software Development, Manufacturing, and Supply Chain sectors. What sets us apart is our AI-powered, in-house software's enabling us to source and screen top talent within hours. This ensures rapid response times, high-quality matches, and virtually zero attrition.
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.
Additional Information
All your information will be kept confidential according to EEO guidelines.