Engineer and Regulatory Specialist (58307)

ATS FAMILY • Colorado Springs, CO

6d • $90,000 - $110,000

About The Position

The Engineer and Regulatory Specialist prepares, reviews, and submits technical documentation for FDA regulatory submissions and provides regulatory and technical consulting services to clients. The role supports responses to FDA requests for additional information and helps resolve regulatory questions throughout submission reviews. It also monitors changes in FDA regulations, guidance, and industry standards to keep submissions current and compliant.

The position creates technical protocols with research-based acceptance criteria for mechanical testing; conducts literature reviews and summarizes documents for technical memoranda; and writes engineering justification memoranda. The specialist advises clients on regulatory pathways, submission strategies, documentation requirements, and regulatory risks, and participates in client meetings, technical discussions, and project reviews. The role manages multiple multidisciplinary projects.

Requirements

• Bachelor’s degree (B.S.) in engineering.
• 1–5 years of experience in an engineering technical position.
• Fluency in 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 skills.
• Ability to work with peers across functions and departments.
• Significant attention to detail and ability to multitask and prioritize multiple endeavors.
• Ability to define problems, collect data, establish facts, and draw valid conclusions.
• Must be a self-starter, flexible, and adaptable.
• Knowledge of FDA regulations as they relate to medical devices.
• Proven experience managing several projects simultaneously.
• Must be a U.S. Person, as defined in the posting, because the position requires access to information subject to ITAR export controls.
• Visual capability to read regulations and documents, and the mental effort and verbal skills to effectively relate potential problems to appropriate personnel.

Nice To Haves

• 1–3 years of compliance experience in an FDA-regulated company.
• Regulatory affairs training, such as RAPS.

Responsibilities

• Prepare, compile, review, and submit technical documentation for FDA regulatory submissions.
• Support responses to FDA requests for additional information and assist in resolving regulatory questions during submission reviews.
• Monitor changes in FDA regulations, guidance documents, and industry standards to keep regulatory submissions current and compliant.
• Create technical protocols with research-based acceptance criteria for mechanical testing.
• Conduct literature reviews by searching, reviewing, and summarizing documents for memoranda, including acceptance criteria for validation activities.
• Advise clients on regulatory pathways, submission strategies, technical documentation requirements, and regulatory risks.
• Participate in client meetings, technical discussions, and project reviews to communicate regulatory expectations, project progress, and potential compliance issues.
• Research and write engineering justification memoranda on various topics.
• Manage multiple multidisciplinary projects related to the role.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level