Biological Safety Specialist (US Remote)

Company: NAMSA
Location: Garland
Posted on: January 17, 2023

Job Description:

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 Specialist Position Summary:
Within this astonishing role of Biological Safety Specialist, there are several strategic and multifaceted levels in which you may qualify, excel and grow: Biological Safety Specialist, Senior Biological Safety Specialist, Principal Biological Safety Specialist, and Sr. Principal Biological Safety Specialist.* Each of these positions will provide scope of project and relevant information to support the creation of proposals while offering opportunities to clients for expansion of the CRO services to be provided by NAMSA.
You will confidently utilize your knowledge and hands on experience in biocompatibility, medical device, writing risk assessments, GLP and non-GLP preclinical studies, data collection, reporting and communications, while displaying a genuine aptitude to learn and grow in this field.
Day-to-day responsibilities include; not limited to:

• Establish and ensure schedule, budget and quality commitments are met for the client.
• Manage (motivate, communicate) 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.
  Other duties, depending on job level, cover:
  • 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 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
  • Performs and summarize literature searches according the ISO 10993-1 Annex C and any other applicable guidance
  • Evaluates and interprets 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
  • Evaluates and determines biological relevance of unexpected results.
    Minimum 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.
    • Fluency in English and local language, if different, required.
    • Knowledge and experience with applicable standards and regulations for medical devices.
    • CRO work experience preferred.
    • 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.
    • Intermediate working experience with Microsoft Word.
    • Advance ability to write and review complex documents.
      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.
      Position descriptions are not intended, and should not be construed to be an exhaustive list of all responsibilities, skills, and efforts or working conditions associated with a job. NAMSA reserves the right to revise duties as needed.

Keywords: NAMSA, Garland , Biological Safety Specialist (US Remote), Accounting, Auditing , Garland, Texas