Job Description:
• Participate in meetings with prospective clients.
• Provide scope of project and relevant information to support the creation of proposals.
• Offer opportunities to clients for expansion of MRO services to be provided by NAMSA.
• Prepares risk assessments, evaluation plans and reports, in compliance with ISO 10993-1 ISO 10993-17 and ISO 14971, for submissions to FDA and other regulatory agencies.
• Evaluates and summarizes biocompatibility and general toxicology data ensuring compliance with the relevant regulatory requirements and standards.
• Working knowledge of FDA and EU MDD and other global medical device regulations and/or biologics regulations, ISO 10993 series, and 14971.
• Ensure biocompatibility studies are in compliance with most recent regulatory requirements.
• Performs and summarizes Clinical Evaluations.
• Provide technical support to lab staff.
• Advise clients on technical issues related to biocompatibility and material characterization.
• Develop proposals for Biological Safety projects.
• Perform biocompatibility gap analysis and write clear concise report.
• Performs and summarizes literature searches.
• Facilitate the collection of test data from other NAMSA entities as they relate to a specific project.
• Evaluates and determines biological relevance of unexpected results.

Qualifications & Technical Competencies:
• Bachelor's degree or equivalent experience in a related field, and a minimum of 5 years of relevant experience; or
• Master's or Doctorate degree or equivalent experience in a related field, and a minimum of 2 years of relevant experience.
• DABT Certification Required
• Knowledge of and experience with Microsoft Word
• Write and review complex documents

Working Conditions:
• The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
• While performing the duties of this job, the employee is regularly required to talk or hear. The employee is frequently required to stand; walk; sit; use hands to finger, handle, or feel and reach with hands and arms. The employee must occasionally lift and/or move up to 25 pounds. Specific vision abilities required by this job include close vision, depth perception, and ability to adjust focus.
• Extensive use of a computer keyboard.