Safety Biology Specialist

Safety Biology Specialist W/M

Apply to the Safety Biology Specialist W/M role at NAMSA.

As part of the Biological Safety and Validation Services, your responsibilities will be the following:

• Establish and ensure schedule, budget and quality commitments are met for the client.
• Actively communicate with internal team members.
• Understand investigational product(s) and high level understanding of the Medical Device Development Process.
• Handle challenging situations, and know when to call-in help.
• Interact as needed with clients, auditors, inspectors, subcontractors, consultants, and other individuals or departments.
• Perform project in compliance with regulations.
• Deliver presentations, including preparation, assembling slides, and speaking.
• Provide feedback regarding project team members using the appropriate performance management tools and processes, in a timely manner.
• 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 NAMSA services.
• 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.
• Evaluate and summarize biocompatibility and general toxicology data ensuring compliance with the relevant regulatory requirements and standards.
• Working knowledge of FDA medical device regulations and/or biologics regulations, ISO 10993 series, and 14971.
• Ensure biocompatibility studies are in compliance with most recent regulatory requirements.
• 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 analyses and write clear concise reports.
• Perform and summarize literature searches.
• Evaluate and interpret standard requirements for clients.
• Write interpretations of standards, test methodology, annotated bibliographies.
• Summarize testing reports for submissions.
• 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.

What we are looking for:

• This position requires a minimum of a Bachelor’s degree or equivalent experience in a related field, and a minimum of 3 years of relevant experience; or a Master’s or Doctorate degree or equivalent experience in a related field, and a minimum of 1 year of relevant experience.
• Fluency in English and local language, if different, required.
• Knowledge and experience with applicable standards and regulations for medical devices.
• Ability to assess/audit compliance of biocompatibility and material characterization results to applicable standards and regulations.
• Ability to develop biological safety documents and reports that are compliant with applicable standards and regulations.
• Knowledge of and experience with Microsoft Word.
• Write and review complex documents.

Please apply on our website:

Entry level

Full-time

Consulting and Research

Research Services