Former FDA Investigator (Mock Inspection/Audit Consultant)

Overview

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.

Key Responsibilities

• Conduct comprehensive mock FDA inspections aligned with current regulatory expectations

• Evaluate quality systems for compliance with FDA QSR and applicable standards (e.g., 21 CFR Part 820, ISO 13485)

• Identify potential compliance risks, gaps, and areas for improvement

• Provide detailed feedback, reports, and remediation recommendations

• Coach and prepare client teams for FDA interactions, including inspection readiness and response strategies

• Stay current on FDA trends, inspection focus areas, and enforcement activities

Qualifications

• Experience as an FDA Investigator (medical device focus required)

• Separated from the FDA within the past 5 years

• Deep knowledge of FDA regulations, inspection processes, and enforcement practices

• Strong understanding of medical device quality systems and manufacturing environments

• Experience conducting audits, inspections, or compliance assessments

• Excellent communication and report-writing skills

Preferred Experience

• Experience supporting FDA inspections or mock audits in a consulting capacity

• Familiarity with CAPA, complaint handling, design controls, and supplier management

• Ability to engage with cross-functional teams and senior leadership

Behaviors

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

Engagement Details

• Project-based / contract opportunities

• Flexible scheduling based on client needs

• Competitive hourly or project-based compensation

Behaviors

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

Behaviors

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

Behaviors

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

Behaviors

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

Behaviors

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

Behaviors

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

Behaviors

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

Behaviors

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

Behaviors

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

Behaviors

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

Behaviors

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

Behaviors

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

Behaviors

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

Behaviors

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

Behaviors

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

Behaviors

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

Behaviors

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

Behaviors

• Action-Oriented
• Approachability
• Building Effective Teams
• Business Acumen