Remote General Engineer — Medical Device Regulatory SME

Tunnell Government Services, Inc.; United States; Remote; USD 120,000 - 150,000; Full time

Job summary

Tunnell Government Services, Inc. seeks a General Engineer or Biomedical Engineer SME to support FDA CDRH ORP lifecycle activities related to device determinations and the Custom Devices program.

Responsibilities include conducting technical and regulatory reviews, evaluating submissions (510(k), De Novo, 513(g)), and coordinating with FDA stakeholders. This telework role requires US citizenship and a strong background in regulatory science.

Qualifications

• Bachelor’s degree in Engineering, Biomedical Engineering or related field is required.
• Seven years of professional experience in engineering, medical devices, regulatory affairs, regulatory science, product development or related field.
• Demonstrated ability to identify, analyze, and assist with data integrity issues in scientific review processes.
• Knowledge of medical device technologies and applicable FDA regulatory frameworks.
• Strong analytical and technical writing abilities with clear communication of complex concepts.
• Excellent verbal communication and interpersonal skills to bridge front-line staff and senior management.

Responsibilities

• Perform technical and regulatory reviews of medical devices, applying engineering principles to assess design, use, performance, and regulatory status.
• Evaluate information for 510(k), De Novo, 513(g) and related regulatory submissions.
• Analyze complex engineering and scientific issues to support regulatory recommendations and decisions.
• Assist in preparation and evaluation of official device determinations, classifications, and regulatory pathways.
• Coordinate with subject matter experts and FDA offices to ensure consistent regulatory standards.

Skills

Seven years experience

Analytical writing

Verbal communication

Teamwork

MS Office proficiency

Education

Bachelor’s degree in Engineering or Biomedical Engineering

Master’s degree in Biomedical Engineering or related field

Tools

Microsoft Office Suite

Job description

Tunnell Government Services, Inc. seeks a General Engineer or Biomedical Engineer SME to support FDA CDRH ORP lifecycle activities related to device determinations and the Custom Devices program.

Responsibilities include conducting technical and regulatory reviews, evaluating submissions (510(k), De Novo, 513(g)), and coordinating with FDA stakeholders. This telework role requires US citizenship and a strong background in regulatory science.