<p>RQM+ is The MedTech CRO, accelerating innovation to patient impact. Our tailored solutions deliver regulatory and quality expertise, FDA-recognized laboratory services, clinical trials, and reimbursement strategies across device types and therapeutic areas to bring life-changing technologies to patients - faster, safer, better.</p> <p>We don't make MedTech. We make MedTech happen.</p> <p>Our experienced teams are cohesive, collaborative, and proactive, constantly seeking to improve and evolve while remaining laser-focused on customer success. RQM+ elevates the MedTech experience through best-in-class service and clear, concise communication. We serve as an extension of our customers establishing and maintaining excellent client and site relationships and providing direct access to our technology platforms for real-time data and study transparency.</p> <p>Job Title: Former FDA Investigator - Medical Device (Mock Inspection Consultant)</p> <p>Overview:</p> <p>We are seeking experienced former FDA Investigators with a strong background in the medical device industry to support our clients as they prepare for upcoming FDA inspections. This is a consulting opportunity to leverage your expertise by conducting mock FDA inspections, identifying compliance gaps, and providing actionable recommendations.</p> <p>Key Responsibilities:</p> <ul> <li>Conduct comprehensive mock FDA inspections aligned with current regulatory expectations </li><li>Evaluate quality systems for compliance with FDA QSR and applicable standards (e.g., 21 CFR Part 820, ISO 13485) </li><li>Identify potential compliance risks, gaps, and areas for improvement </li><li>Provide detailed feedback, reports, and remediation recommendations </li><li>Coach and prepare client teams for FDA interactions, including inspection readiness and response strategies </li><li>Stay current on FDA trends, inspection focus areas, and enforcement activities </li></ul> <p>Qualifications:</p> <ul> <li>Experience as an FDA Investigator (medical device focus required) </li><li>Separated from the FDA within the past 5 years </li><li>Deep knowledge of FDA regulations, inspection processes, and enforcement practices </li><li>Strong understanding of medical device quality systems and manufacturing environments </li><li>Experience conducting audits, inspections, or compliance assessments </li><li>Excellent communication and report-writing skills </li></ul> <p>Preferred Experience:</p> <ul> <li>Experience supporting FDA inspections or mock audits in a consulting capacity </li><li>Familiarity with CAPA, complaint handling, design controls, and supplier management </li><li>Ability to engage with cross-functional teams and senior leadership </li></ul> <p>Engagement Details:</p> <ul> <li>Project-based / contract opportunities </li><li>Flexible scheduling based on client needs </li><li>Competitive hourly or project-based compensation </li></ul> <p>Behaviors: Action-Oriented, Approachability, Building Effective Teams, Business Acumen, Career Ambition, Composure, Courage (Managerial), Customer Focus, Decision Quality, Informing, Integrity & Trust, Interpersonal Savvy, Planning</p> <p>Work Environment/Physical Demands: This job operates in a professional office environment. This role routinely uses standard office equipment such as computers, phones, photocopiers and filing cabinets. The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. The employee is occasionally required to sit; climb or balance; and stoop, kneel, crouch or crawl. The employee must frequently lift or move objects up to 10 pounds and occasionally lift or move objects up to 25 pounds.</p> <p>Being an industry leader in Medtech is just the beginning for RQM+. We consider our employees our biggest asset and we invest heavily in ongoing learning and development. Providing a rewarding place to work is rooted deep in our core values. From an industry leading compensation package to a deeply engrained focus on work life balance, RQM+ has a unique offering for regulatory and quality professionals. At RQM+, you are not just another employee, you are a member of RQM+ family. Make your impact today!</p> <p>We invite you to apply if you have an interest in learning more about our organization and beginning your journey with us.</p> <p>Job Opportunity Verification</p> <p>At RQM+, we prioritize the security of our job applicants. To ensure a safe application process:</p> <p>All legitimate RQM+ job opportunities are listed on our official careers page: rqmplus.com/careers</p> <p>Every candidate going through the interview process will participate in a voice and/or video interview.</p> <p>Exercise caution with unsolicited job offers or requests for sensitive information.</p>