Senior Biocompatibility & Toxicology Scientist

North American Science Associates, Inc.; Northern (KY); Hybrid; USD 84,000 - 163,000; Full time

Job summary

NAMSA is seeking a Senior Biocompatibility & Regulatory Affairs Specialist to join our team in the United States. You will drive biocompatibility evaluations, prepare risk assessments, and ensure compliance with ISO 10993, FDA regulations, and related standards for medical devices.

Responsibilities include authoring reports, supporting proposals, and advising clients on technical issues. The role requires strong documentation skills, familiarity with regulatory requirements, and collaboration

Qualifications

• Bachelor’s degree or equivalent in a related field with 5+ years of relevant experience; or a Master’s/Doctorate with 2+ years.
• Fluency in English; local language if applicable.
• Knowledge of standards and regulations for medical devices (ISO 10993, FDA, ISO 14971).
• Ability to develop biological safety documents and reports.
• Proficient in creating clear, compliant documentation in Word.

Responsibilities

• Participate in meetings with prospective clients and support proposal development.
• Prepare risk assessments and evaluation plans for submissions to FDA and regulators.
• Evaluate biocompatibility data and ensure regulatory compliance.
• Advise clients on technical issues related to biocompatibility and materials.
• Write and summarize testing and literature reports for submissions.
• Collaborate with NAMSA teams to meet schedules, budgets, and quality targets.

Skills

English fluency

Documentation writing

Regulatory knowledge

Communication

Microsoft Word

Education

Bachelor's degree or equivalent experience

Master's or Doctorate degree

Tools

Microsoft Word

Job description

NAMSA is seeking a Senior Biocompatibility & Regulatory Affairs Specialist to join our team in the United States. You will drive biocompatibility evaluations, prepare risk assessments, and ensure compliance with ISO 10993, FDA regulations, and related standards for medical devices.

Responsibilities include authoring reports, supporting proposals, and advising clients on technical issues. The role requires strong documentation skills, familiarity with regulatory requirements, and collaboration