FDA Regulatory Engineer & Submissions Specialist

Applied Technical Services, LLC; Colorado Springs (CO); In loco; USD 90.000 - 110.000; Tempo pieno

Descrizione del lavoro

Applied Technical Services, LLC in Colorado Springs seeks an Engineer and Regulatory Specialist to prepare, review, and submit FDA documentation and provide regulatory consulting to clients.

The role requires a bachelor’s degree in engineering, 1–5 years of engineering experience, knowledge of FDA medical device regulations, strong writing skills, and the ability to manage multiple projects across disciplines.

Competenze

• Bachelor’s degree in engineering and 1-5 years engineering experience.
• Knowledge of FDA regulations as they relate to medical devices.
• Excellent written and verbal communication with attention to detail.

Mansioni

• Prepare, compile, review, and submit FDA regulatory submissions.
• Advise clients on regulatory pathways and submission strategies.
• Monitor FDA guidance and industry standards for compliance.
• Manage multiple cross-discipline projects.

Conoscenze

Microsoft Word

Microsoft Excel

Technical writing

Attention to detail

Verbal skills

Formazione

Bachelor’s degree in engineering

Regulatory affairs training (e.g. RAPS)

Strumenti

Journal databases

Regulatory databases

Descrizione del lavoro

Applied Technical Services, LLC in Colorado Springs seeks an Engineer and Regulatory Specialist to prepare, review, and submit FDA documentation and provide regulatory consulting to clients.

The role requires a bachelor’s degree in engineering, 1–5 years of engineering experience, knowledge of FDA medical device regulations, strong writing skills, and the ability to manage multiple projects across disciplines.