Senior Biomedical Engineer - Remote Device Regulatory Lead

ICA.ai; Arlington (VA); Remote; USD 120,000 - 180,000; Full time

Benefits offered by this job

Health Insurance

Dental Insurance

Vision Insurance

Health Spending Account

Flexible Spending Account

Life and Disability Insurance

401(k) plan with company match

Paid Time Off

Education and Professional Development

Remote work from anywhere within the U

Job summary

ICA.ai is seeking a senior Biomedical Engineer to lead regulatory review activities for medical device submissions, translate complex requirements into clear, testable product needs, and ensure compliance across the total product life cycle.

You will collaborate with cross-functional teams, mentors junior staff, and contribute to FDA-focused review processes, quality assurance, and risk assessment while upholding stringent documentation standards.

Qualifications

• Bachelor's degree in Biomedical Engineering or related field with 8+ years of medical device experience; or Master's with 6+ years; or PhD with 3+ years.
• Experience in medical device regulatory review, regulatory affairs, quality assurance, clinical review, or related regulated field.
• Working knowledge of FDA medical device regulations, premarket pathways (510(k), De Novo, PMA, IDE), and applicable FDA guidance.
• Working knowledge of device quality and risk standards.
• Experience analyzing complex clinical or performance datasets and evaluating study design and data quality for device evidence.
• Proven ability to lead projects, manage competing priorities under pressure, and deliver high-quality work with minimal oversight.
• Exceptional attention to detail and organizational skills.
• Excellent written and verbal communication skills, including the ability to brief technical and non-technical audiences.
• Ability to obtain and maintain a Public Trust clearance.

Responsibilities

• Serve as a technical lead and device subject matter resource on cross-functional teams throughout the medical device total product life cycle, from pre-market review through postmarket surveillance
• Analyze medical device submissions and records (e.g., 510(k), De Novo, PMA, IDE, and postmarket submissions)
• Evaluate issues raised by subject matter experts across disciplines during device review, assess their significance to the device's safety, effectiveness, and benefit-risk determination, and analyze how those issues are conveyed to stakeholders and resolved
• Identify patterns, gaps, and opportunities for improvement across device types, regulatory pathways, and review divisions
• Build and maintain a repository of representative device submissions and review precedents to support reviewer needs and requirements definition
• Define meaningful alert categories, priorities, reviewer actions, and escalation paths
• Evaluate alert relevance, false positives, false negatives, evidence quality, usability, and reviewer effort
• Develop and refine SOPs, RWE review protocols, and RWE standards for device review, and recommend improvements grounded in analytic findings and current FDA guidance
• Lead and support device risk analysis activities, including hazard identification, risk estimation, and benefit-risk assessment
• Author and present research findings, technical reports, and recommendations to senior stakeholders and leadership
• Mentor and provide technical guidance to junior engineers and analysts, including review of their work products
• Ensure adherence to SOPs and maintain thorough documentation of all review work

Skills

Regulatory review

FDA regulations

Project leadership

Data analysis

Written & verbal communication

Risk assessment

Education

Bachelor's in Biomedical Engineering

Master's degree

PhD

Job description

ICA.ai is seeking a senior Biomedical Engineer to lead regulatory review activities for medical device submissions, translate complex requirements into clear, testable product needs, and ensure compliance across the total product life cycle.

You will collaborate with cross-functional teams, mentors junior staff, and contribute to FDA-focused review processes, quality assurance, and risk assessment while upholding stringent documentation standards.