Engineer and Regulatory Specialist (Medical Devices)

Location: Colorado Springs, CO 80918; U.S. Persons Only due to ITAR export-control requirements

Salary: $90,000.00–$110,000.00 per year

Company

hirify.global provides testing, inspection, certification, and compliance services across manufacturing, power generation, aerospace, medical, and defense markets.

What you will do

• Prepare, compile, review, and submit technical documentation for FDA regulatory submissions.
• Respond to FDA requests for additional information and help resolve regulatory questions during submission reviews.
• Monitor FDA regulations, guidance, and industry standards to keep submissions current and compliant.
• Create research-based mechanical testing protocols and acceptance criteria; conduct literature reviews and write engineering justification memos.
• Advise clients on regulatory pathways, submission strategies, technical documentation, and compliance risks.
• Participate in client meetings and project reviews while managing multiple multidisciplinary projects.

Requirements

• Bachelor’s degree in engineering.
• 1–5 years of experience in an engineering technical position, including recommended 1–3 years of compliance experience in an FDA-regulated company.
• Knowledge of FDA regulations relating to medical devices and regulatory affairs training such as RAPS.
• Fluent use of Microsoft Word and Excel and technical journal database searching.
• Ability to read, analyze, and interpret scientific and technical journals, financial reports, and legal documents.
• Outstanding written and verbal communication skills, with demonstrated effective writing ability.
• Ability to collaborate across functions and departments, manage several projects simultaneously, multitask, prioritize, define problems, collect data, establish facts, and draw valid conclusions.
• Strong attention to detail; self-starter who is flexible and adaptable.
• Must qualify as a U.S. Person under ITAR, including a U.S. citizen or national, lawful permanent resident, refugee, or asylee.

Culture & Benefits

• Full-time employment supporting clients across large, stable end markets.
• Work involves continuous attention to detail, visual document review, and verbal communication of potential problems.
• Collaboration with peers across functions and departments and participation in client-facing technical discussions.