Toxicologist

NAMSA

4d•Onsite

About The Position

NAMSA pioneered the industry and was the first independent company in the world to focus solely on medical device materials for safety. NAMSA started testing medical devices before the U.S. Food and Drug Administration started regulating such products in 1976. We are shaping the industry. NAMSA has been a key contributor to the development of the test methods that govern our industry. We have become the industry’s premier provider. We provide support for clients during every step of the product development lifecycle and beyond. Come and work for an organization with the: Vision to inspire innovative MedTech solutions that advance global healthcare, improve patient lives and accelerate Client success and the Mission to deliver best-in-class global MedTech development solutions through our people, expertise and technology by adhering to our core Values: Act with integrity in everything we do. Provide best-in-class customer experiences. Develop superior talent and deliver expertise. Respond with agility and provide timely results. Embrace collaboration, diverse perspectives and ideas.

Requirements

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 knowledge of FDA and EU MDD and other global medical device regulations and/or biologics regulations, ISO 10993 series, and 14971.

Responsibilities

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.
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.