Senior Biocompatibility & Regulatory Scientist

North American Science Associates, Inc.; Northwood (OH); On-site; USD 84,000 - 163,000; Full time

Job summary

NAMSA is seeking a Senior Biocompatibility & Regulatory Affairs Specialist to support medical device submissions and risk assessments. You will assess data, prepare reports, and advise clients on regulatory issues, ensuring compliance with ISO 10993, FDA regulations, and related standards.

Join NAMSA in Ohio to lead biocompatibility programs, collaborate across teams, and help expand service offerings while delivering high-quality documentation and timely results.

Qualifications

• Bachelor’s or equivalent in a related field with 5+ years of relevant experience, or advanced degree with 2+ years.
• Fluency in English; local language if different.
• Knowledge of standards and regulations for medical devices.
• Ability to develop biological safety documents and reports that comply with standards.
• Knowledge of and experience with Word and writing complex documents.

Responsibilities

• Participate in meetings with prospective clients.
• Provide scope of project and information to support proposals.
• Offer opportunities to expand NAMSA services to clients.
• Prepare risk assessments and reports per ISO 10993-1, ISO 10993-17, ISO 14971 for FDA submissions.
• Evaluate biocompatibility data ensuring regulatory compliance.
• Advise clients on biocompatibility and material characterization issues.
• Summarize testing reports for submissions.
• Establish schedules, budgets, and quality commitments with clients.
• Interact with clients, auditors, inspectors, subcontractors, and other stakeholders.
• Author blog posts or white papers.
• Identify and evaluate applicable standards and guidance documents.

Skills

Regulatory knowledge

Biocompatibility

Compliance auditing

Safety reporting

Technical writing

MS Word

Education

Bachelor’s degree or related field

Master’s or Doctorate in related field

Tools

MS Word

Job description

NAMSA is seeking a Senior Biocompatibility & Regulatory Affairs Specialist to support medical device submissions and risk assessments. You will assess data, prepare reports, and advise clients on regulatory issues, ensuring compliance with ISO 10993, FDA regulations, and related standards.

Join NAMSA in Ohio to lead biocompatibility programs, collaborate across teams, and help expand service offerings while delivering high-quality documentation and timely results.