Clinical Scientist at Techtrueup

Newark, Delaware, United States -

Full Time

Start Date

Immediate

Expiry Date

12 Jun, 26

Salary

0.0

Posted On

14 Mar, 26

Experience

5 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Clinical Evaluation Plans, Clinical Evaluation Reports, CE Mark Submissions, Literature Reviews, Clinical Data Analysis, Regulatory Submissions, Investigator Brochures, Clinical Study Protocols, Clinical Study Reports, Risk Documentation, Product Labeling, EU MDR Compliance, GCP Compliance, Technical Writing, Cross-functional Collaboration, Medical Devices

Industry

Human Resources Services

Description

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.

Responsibilities

The Clinical Scientist will be responsible for developing Clinical Evaluation Plans (CEP) and Clinical Evaluation Reports (CER) to support CE Mark regulatory submissions for medical devices. Key duties include conducting literature reviews, analyzing clinical data, and collaborating with various internal teams to support the clinical strategy.