Biocompatibility & Toxicology Specialist

North American Science Associates, Inc.; Northwood (OH); On-site; USD 69,000 - 134,000; Full time

Job summary

NAMSA is a leading independent MedTech-focused organization serving clients through the full product development lifecycle. This role centers on biocompatibility, regulatory compliance, and technical reporting to support FDA submissions.

The ideal candidate will leverage five-plus years of relevant experience, plus a degree in a related field, to prepare risk assessments, evaluate data, and advise clients on issues related to biocompatibility and material characterization. Travel may be required.

Qualifications

• Bachelor’s degree or equivalent experience in a related field with 5+ years of relevant experience, or Master/Doctorate with 2+ years.
• Fluency in English and local language, if different, required.
• Knowledge of standards and regulations for medical devices.
• Ability to assess/audit compliance of biocompatibility results to standards.
• Ability to develop biological safety documents and reports.
• Knowledge of Microsoft Word and the ability to write/review complex documents.

Responsibilities

• Participate in meetings with prospective clients.
• Provide scope of project and information to support proposals.
• Offer opportunities to clients for expansion of NAMSA services.
• Prepare risk assessments, evaluation plans and reports for FDA/regulatory submissions.
• Evaluate and summarize biocompatibility and toxicology data for regulatory compliance.
• Advise clients on biocompatibility and material characterization issues.
• Summarize testing reports for submissions.

Skills

Biocompatibility knowledge

Regulatory understanding

Technical writing

English fluency

Education

Bachelor’s degree or equivalent experience

Master's or Doctorate degree

Tools

Microsoft Word

Job description

NAMSA is a leading independent MedTech-focused organization serving clients through the full product development lifecycle. This role centers on biocompatibility, regulatory compliance, and technical reporting to support FDA submissions.

The ideal candidate will leverage five-plus years of relevant experience, plus a degree in a related field, to prepare risk assessments, evaluate data, and advise clients on issues related to biocompatibility and material characterization. Travel may be required.