North American Science Associates (NAMSA) started testing medical devices before the U.S. Food and Drug Administration started regulating such products in 1976, thus pioneering the industry. NAMSA was the first independent company in the world to focus solely on medical device materials for safety. Join our company's global expansion as we continue to provide support for clients during every step of the product development lifecycle and beyond.Biological Safety Scientist Job Description
Within this unique role of Biological Safety Scientist, there are several strategic and multifaceted levels in which you may qualify: Biological Safety Scientist, Senior Biological Safety Scientist, Principal Biological Safety Scientist, and Sr. Principal Biological Safety Scientist.*
You will also utilize your exceptional writing skills to prepare 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.Day-to-day responsibilities include:
- Evaluates and summarizes biocompatibility and general toxicology data ensuring compliance with the relevant regulatory requirements and standards.
- Consult with clients to ensure biocompatibility studies are in compliance with most recent regulatory requirements.
- Check in with clients on technical issues related to biocompatibility and material characterization.
- Perform biocompatibility gap analysis and write clear concise report.
- Perform and summarize literature searches.
- Facilitate the collection of test data from other NAMSA entities as they relate to a specific project.
- Evaluate and determine biological relevance of unexpected results.
- Proven Biocompatibility Testing and Toxicology work experience
- Expert knowledge of FDA medical device regulations and/or biologics regulations, ISO 10993 and 14971.
- Strong Project Management and Problem-Solving skills.
- Exceptional Verbal and Written Communications abilities.
- Bachelor's degree or equivalent experience in a related field, and 5+ years of relevant experience; or
- Master's or Doctorate (PhD) degree
- One (1) year of relevant work experience up to 15+ years for senior level associate roles.
NAMSA is a responsive employer offering competitive benefits packages, exceptional training, opportunities for growth, and more, wrapped up in a meaningful career. Please apply with your LinkedIn profile for a thorough review and an immediate phone discussion.