FDA Inspection Readiness & Front-Room Training Consultant

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.

We don’t make MedTech. We make MedTech happen.

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.

Job Summary:

Our Client is preparing for an FDA inspection of its Quality Management System and is evaluating the readiness of personnel who may serve in front-room roles during an inspection.

The organization currently has a limited number of individuals with significant front-room experience and is re-establishing a qualified pool of personnel capable of supporting inspection activity across its sites.

Our Client wants to ensure front room personnel are capable of guiding the inspectors through the process and system and instilling credibility of process knowledge, system awareness, and management of the quality system. Personnel need the ability to narrate that story credibly and to appropriately direct an FDA investigator's line of inquiry. This is a soft-skills capability gap rather than a procedural knowledge gap.

Primary Responsibilities:

Front-Room Readiness Assessment & Coaching

Assessment and soft-skills coaching of personnel who may serve in front-room roles during an FDA inspection.

Activities:

• Conduct and observe mock inspection interactions using realistic investigator behavior, questioning technique, and pressure.

• Evaluate individual readiness for front-room roles against defined readiness criteria.

• Coach personnel on investigator engagement — building rapport, reading investigator intent, and managing the interaction.

• Coach narrative and storytelling skills: presenting the intent and history behind documentation rather than relying on the documents to speak for themselves.

• Coach directional control — appropriately guiding an investigator toward relevant, well-supported areas of the quality system.

• Coach listening and response discipline: answering only what is asked, managing pauses and silence, and avoiding volunteering unnecessary information.

• Provide feedback on handling inspection nuances, including unexpected requests, escalating questioning, and ambiguous or leading questions.

• Deliver individualized feedback to each participant, including specific strengths and development areas.

• Confirm and document whether each individual is ready to represent the organization during an FDA inspection.

• Debrief site leadership on aggregate readiness, capability gaps, and recommended next steps.

Inspection Documentation Package Review

Independent experienced review of inspection documentation and supporting objective evidence.

Activities:

• Review observations and the supporting objective evidence assembled for each.

• Confirm documentation alignment and accuracy across the package.

• Confirm that the evidence provided substantiates the intended response and would withstand investigator challenge.

• Identify misplaced, inconsistent, duplicated, or missing documentation.

• Assess whether the package supports the narrative front-room personnel will be expected to present.

• Provide written feedback with prioritized recommendations for remediation of the package.

Anticipated locations include Pittsburgh, India, and additional Client sites to be confirmed.

Education/Work Experience/Requirements:

• Former FDA investigator with Medical Devices
• Strong, current FDA inspection experience across medical device / QMS inspections
• Demonstrated experience coaching and developing front-room inspection personnel
• Ability to review and assess inspection response packages and supporting objective evidence
• Able to replicate authentic investigator behavior in mock conditions and coach soft skills credibly
• Willing and able to travel internationally, including to India

Behaviors: Action-Oriented, Approachability, Building Effective Teams, Business Acumen, Career Ambition, Composure, Courage (Managerial), Customer Focus, Decision Quality, Informing, Integrity & Trust, Interpersonal Savvy, Planning

Work Environment & Physical Requirements:

Field/travel-based roles (e.g., client site visits, audits):
This role involves regular travel to client and partner sites, which may include varying office and facility environments. The employee should be able to travel independently, navigate different facility types, and occasionally lift or carry items up to 25 lbs (e.g., equipment, materials, luggage).

These requirements reflect what's typically needed to perform the core functions of this role. If you require an accommodation to perform any aspect of this position, please let us know — we're happy to discuss options.

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!

We invite you to apply if you have an interest in learning more about our organization and beginning your journey with us.

Job Opportunity Verification:

At RQM+, we prioritize the security of our job applicants. To ensure a safe application process:

• All legitimate RQM+ job opportunities are listed on our official careers page: rqmplus.com/careers
• Every candidate going through the interview process will participate in a voice and/or video interview.
• Exercise caution with unsolicited job offers or requests for sensitive information.