Senior Biocompatibility Toxicologist – MedTech Regulatory

North American Science Associates, Inc.; Northern (KY); Hybrid; USD 69,000 - 134,000; Full time

Job summary

NAMSA, a leading MedTech development and testing organization, seeks a Biocompatibility and Regulatory Specialist to support client projects. You will participate in client meetings, scope projects, and propose expanded services while preparing ISO-compliant risk assessments and reports for FDA submissions.

You will evaluate biocompatibility data, apply FDA/ISO requirements, and advise clients on technical regulatory questions.

Qualifications

• 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

Responsibilities

• 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

Job description

NAMSA, a leading MedTech development and testing organization, seeks a Biocompatibility and Regulatory Specialist to support client projects. You will participate in client meetings, scope projects, and propose expanded services while preparing ISO-compliant risk assessments and reports for FDA submissions.

You will evaluate biocompatibility data, apply FDA/ISO requirements, and advise clients on technical regulatory questions.