Biological Safety Specialist (US Remote)
Posted on: January 17, 2023
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
- Interact as needed with clients, auditors, inspectors,
subcontractors, consultants, and other individuals or
- 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
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
- 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
- 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
- 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
- Fluency in English and local language, if different,
- 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
- 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
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
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