FDA Submissions Engineer & Regulatory Specialist

Applied Technical Services, LLC; Colorado Springs (CO); On-site; USD 70,000 - 110,000; Full time

Job summary

Applied Technical Services, LLC is a leading provider of testing, inspection, certification, and compliance services. The Engineer and Regulatory Specialist will prepare FDA documentation and advise clients on regulatory strategies.

The role requires strong technical writing, regulatory knowledge, and the ability to manage multiple projects across functions while staying current with FDA guidance and industry standards.

Qualifications

• Bachelor’s degree in engineering with exposure to regulatory requirements.
• Experience reading and interpreting FDA guidelines and medical device regulations.
• Strong writing, documentation, and multitasking abilities.

Responsibilities

• Prepare, compile, review, and submit FDA regulatory documentation.
• Respond to FDA requests for information and advise on regulatory pathways.
• Monitor FDA regulations and industry standards to ensure compliance.
• Create technical protocols and perform literature reviews for validation.
• Manage multiple projects across cross-functional teams.

Skills

Microsoft Word

Microsoft Excel

Technical writing

Regulatory knowledge

Document review

Education

Bachelor's degree in engineering

Regulatory affairs training

Tools

Journals databases

Job description

Applied Technical Services, LLC is a leading provider of testing, inspection, certification, and compliance services. The Engineer and Regulatory Specialist will prepare FDA documentation and advise clients on regulatory strategies.

The role requires strong technical writing, regulatory knowledge, and the ability to manage multiple projects across functions while staying current with FDA guidance and industry standards.