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.
Compensation Target:
$75,000.00Job Description:
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 services to be provided by NAMSA
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
Perform biocompatibility gap analyses and write clear concise reports
Performs and summarize literature searches
Facilitate the collection of test data from other NAMSA entities as they relate to a specific project
Establish and ensure schedule, budget and quality commitments are met for the client
Evaluate and determine biological relevance of unexpected results
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
Author blog posts or white papers
Summarize testing reports for submissions
Able to identify and evaluate Standards and Guidance Documents applicable to client’s device
Other duties as assigned
Qualifications & Technical Competencies:
Bachelor’s degree or equivalent experience in a related field, and a minimum of 5 years of relevant experience; or Masters or Doctorate degree, and a minimum of 2 years of relevant experience required
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
Working Conditions:
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
While performing the duties of this job, the employee is regularly required to talk or hear. The employee is frequently required to stand; walk; sit; use hands to finger, handle, or feel and reach with hands and arms.
The employee must occasionally lift and/or move up to 50 pounds (23 kgs).
Frequent use of telephone and video conferencing tools.
Extensive use of computer keyboard and mouse; prolonged periods of sitting.
Noise level in the work environment is usually moderate.
Occasional Travel may be required.
If there is any discrepancy between the above and federal and local legal requirements, the legal requirements apply.
The compensation grade range for this position is:
$68,800.00 - $133,700.00 -
Annual
Please Note: Individual base pay depends on various factors, in addition to primary work location, such as complexity and responsibility of role, job duties/requirements, and relevant experience and skills.
NAMSA is an equal employment opportunity company.
NAMSA participates in pre-employment background and drug screen processes aligned to local, state and federal laws.
NAMSA is a pioneering independent company that specializes in medical device materials testing and safety, having been the first of its kind in the world when it was founded. The company has been instrumental in shaping the medical device industry, including contributing to the development of test methods that govern the sector. NAMSA provides comprehensive support for clients throughout the entire product development lifecycle and beyond, serving as the industry's premier provider of MedTech development solutions. The company operates through a global business model with multiple client portal systems including NAMSA 360, Connect, and Flightlog, and is committed to delivering best-in-class solutions through their people, expertise, and technology.
