Engineer and Regulatory Specialist

ATS FAMILY • Colorado Springs, CO

6d • $90,000 - $110,000 • Onsite

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, tracks regulatory and standards changes, and advises clients on regulatory pathways, submission strategies, documentation requirements, and regulatory risks. It also develops research-based protocols and acceptance criteria for mechanical testing, performs literature reviews, writes engineering justification memos, and 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 communication skills and demonstrated effective writing skills.
• Ability to work with peers across functions and departments.
• Significant attention to detail.
• Knowledge of FDA regulations as they relate to medical devices.
• Proven ability to manage several projects simultaneously, multitask, and prioritize multiple endeavors.
• Ability to define problems, collect data, establish facts, and draw valid conclusions.
• Self-starter who is flexible and adaptable.
• Visual capability to read regulations and documents, and mental effort and verbal skills to communicate potential problems to appropriate personnel.
• Must be a U.S. Person as defined in the posting, due to access to information subject to ITAR export controls.

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 help resolve regulatory questions during submission review.
• Monitor 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 searches, reviews, and summaries for documents such as memos on 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 memos on various topics.
• Manage multiple multidisciplinary projects.

What This Job Offers

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