FDA Regulatory Engineer & Submissions Specialist

Applied-Technical-Services-LL; Colorado Springs (CO); On-site; USD 75,000 - 110,000; Full time

Job summary

Applied Technical Services, LLC seeks an Engineer and Regulatory Specialist to prepare, review, and submit FDA regulatory documentation for medical device submissions. You will support information requests, monitor regulatory changes, and craft protocols and memos to ensure compliance.

You will advise clients on regulatory pathways, participate in technical discussions, and manage multiple multidisciplinary projects while maintaining meticulous attention to detail and strong communication skills.

Qualifications

• Bachelor’s degree in engineering or related field.
• Knowledge of FDA regulations and regulatory submissions for medical devices.
• Strong written and verbal communication skills; ability to manage multiple projects.

Responsibilities

• Prepare, review, and submit FDA regulatory documentation for submissions.
• Support FDA requests for information and resolve regulatory questions.
• Monitor FDA regulations and industry standards to keep submissions compliant.
• Create technical protocols and literature reviews for validation activities.
• Advise clients on regulatory pathways and submission strategies.
• Participate in client meetings and project reviews to communicate regulatory expectations.

Skills

Regulatory writing

FDA regulations

Project management

Attention to detail

Communication skills

Education

Bachelor's degree in engineering

Tools

Microsoft Word

Microsoft Excel

Literature databases

Job description

Applied Technical Services, LLC seeks an Engineer and Regulatory Specialist to prepare, review, and submit FDA regulatory documentation for medical device submissions. You will support information requests, monitor regulatory changes, and craft protocols and memos to ensure compliance.

You will advise clients on regulatory pathways, participate in technical discussions, and manage multiple multidisciplinary projects while maintaining meticulous attention to detail and strong communication skills.