Regulatory Affairs Engineer: FDA 510(k) Submissions Lead

Innovative Health LLC; Scottsdale (AZ); On-site; USD 90,000 - 120,000; Full time

Job summary

Innovative Health LLC is seeking a Regulatory Affairs Engineer in Scottsdale, AZ, to lead regulatory submissions and maintain compliance across FDA and international bodies. The role requires coordinating across engineering, QA, and operations to ensure complete and accurate regulatory documentation.

The ideal candidate has a technical degree with medical device experience, strong writing skills, and a proactive, collaborative approach to handling multiple projects in a fast-paced environment.

Qualifications

• Bachelor's degree in a technical field and at least three years of medical device experience.
• Experience with FDA 21 CFR Part 820 and 510(k) submissions.
• Knowledge of Canadian MDR, MDSAP, ISO standards preferred.
• Ability to manage multiple projects and coordinate cross-functional teams.
• Strong written and verbal communication; ability to write technical documents.

Responsibilities

• Prepare and submit FDA 510(k) documentation for clearance.
• Support submissions to international regulatory bodies.
• Review complaints and adverse events for MDR submissions.
• Review test protocols, reports, and documentation for regulatory accuracy.
• Participate in project teams, risk management, and design reviews.
• Provide regulatory assessments for manufacturing changes and validations.
• Assist audits and respond to audit findings.
• Review change orders, CAPA, and related documentation.
• Assist with label/IFU development for compliance.
• Review promotional materials for regulatory compliance.
• Maintain knowledge base of regulatory requirements.
• Develop and implement company policies and procedures.
• Archive regulatory documentation.

Skills

Regulatory affairs

Cross-functional collaboration

Technical writing

Quality systems

Self-starter

Education

Bachelor's degree in technical field

Tools

Word

PowerPoint

Excel

Project

Minitab

Job description

Innovative Health LLC is seeking a Regulatory Affairs Engineer in Scottsdale, AZ, to lead regulatory submissions and maintain compliance across FDA and international bodies. The role requires coordinating across engineering, QA, and operations to ensure complete and accurate regulatory documentation.

The ideal candidate has a technical degree with medical device experience, strong writing skills, and a proactive, collaborative approach to handling multiple projects in a fast-paced environment.