Scientist III

The Fountain Group is currently seeking a Scientist III for a prominent client of ours. This position is located in Branchburg, NJ. Details for the position are as follows:

• Pay: $50-57/hr.
• 8-month assignment with possibility for extension or conversion based on performance and budget.
  
  

Responsibilities:

• Function as Subject Matter Expert for ISO-10993 (biocompatibility) assessment management with minimal supervision. This will include the design, execution and interpretation of biocompatibility evaluation strategies and programs according to relevant regulatory requirements, including biological risk assessments, technical reports, technical memoranda and other documents for internal and external distribution, including regulatory submissions.
• Responsible for creating detailed Project Plans including scientific strategy and realistic deliverables with timelines. Actively involved in the planning, execution and management of experimental studies for the safety characterization of Client and existing products.
• May serve as a sub-team or core-team member, providing support as needed for all project Teams.
• Support for on-market products, including global change-control activities as they relate to biocompatibility. Requires interacting with Manufacturing Sites.
• Maintain knowledge of medical device regulations to assure compliance and conformance of programs for evaluation of medical device and other products. This includes performing gap analysis relevant to changes in biocompatibility standards or guidance.
• Prepare and deliver technical presentations to internal and external stakeholders with minimal supervision. Assist the team in functional training initiatives.
• Build and maintain strong connections and relationships with Contract Research Organizations, Toxicologists and Consultants for Biological Risk Assessments as needed.
  
  

Qualifications:

• Bachelor's Degree in Life Science/Biomedical Engineering or related field with minimal 6 years of experience in a scientific role in the medical device or pharma industry or Master's degree (with thesis) in Life Science/Biomedical Engineering or related field with at least 4 years of experience in a scientific role in the medical device or pharma industry.
• Significant experience and knowledge of medical device and combination product regulations.
• Experience managing outsourced contract research (GLP, non-GLP, GMP activities).
• Strong knowledge of ISO-10993 Standards, FDA Guidance and Regulations, EU/MDR and Animal Welfare Regulations.
• Understanding of on-market product support with respect to change control and quality systems.
• Knowledge of Good Documentation Practices, maintain accurate documentation & related record retention documentation.
• Proficient in required software including Word, Excel, PowerPoint, and Outlook, and statistical software.
  
  

If you are interested in hearing more about the position, please respond to this posting with your resume attached.

Please forward this posting to any friends or colleagues as we do offer a Referral Bonus for any candidate hired.

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