Associate Toxicologist

namsa; United States; On-site; USD 69,000 - 134,000; Full time

Job summary

NAMSA is seeking a Biocompatibility/Regulatory professional in the United States to support client engagements and regulatory submissions. You will evaluate data, prepare risk assessments, and assist with proposal development for medical device projects.

Ideal candidates have strong knowledge of ISO 10993-1, ISO 10993-17, 14971 and FDA requirements, plus experience in writing complex regulatory documents and providing technical client support.

Qualifications

• Bachelor's degree or equivalent with 5+ years of relevant experience; or advanced degree with 2+ years.
• Fluency in English; local language if applicable.
• Knowledge of medical device standards and regulations (ISO 10993, 14971, FDA).

Responsibilities

• Participate in meetings with prospective clients.
• Provide project scope and information to support proposals.
• Advise clients on biocompatibility and material characterization.
• Prepare risk assessments and evaluation plans for regulatory submissions.
• Summarize biocompatibility data and align with regulatory requirements.
• Ensure studies comply with current regulatory standards.

Skills

Client meetings

Proposal scoping

Biocompatibility knowledge

Regulatory knowledge

Technical writing

Education

Bachelor's degree or equivalent experience

Master's or Doctorate (advantage)

Tools

Microsoft Word

Job description

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:

$75,000.00

Job 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 sc