Customer Quality Regulatory Inquiry Manager

Jobtailor; Colorado; On-site; USD 120,000 - 180,000; Full time

Job summary

Jobtailor is seeking a regulatory inquiries leader to coordinate global regulatory responses for post-market quality activities and to establish a consolidated operating model. You will lead about seven professionals, drive execution, and ensure timely, evidence-based communications to FDA, EU MDR, and other authorities.

The role requires strong cross-functional collaboration with Regulatory Affairs, Legal, and Quality teams, plus a track record of delivering executive-level updates and

Qualifications

• Bachelor’s degree and minimum of 5 years relevant experience, or advanced degree with minimum of 3 years of prior relevant experience
• Minimum of 2 years of prior experience supervising or managing others
• Experience managing new or growing teams
• Knowledge of FDA, EU MDR, and other global regulatory requirements
• Experience in medical device quality, regulatory affairs, post-market surveillance, complaint handling, regulatory reporting, field actions or related regulated healthcare environments
• Demonstrated experience leading cross-functional work in a regulated environment
• Strong written and verbal communication and stakeholder management skills
• Knowledge of Lean Six Sigma Black Belt or similar methodologies
• Ability to deliver executive-level presentations and communicate complex topics
• Experience implementing process automation and workflow optimization

Responsibilities

• Lead a team coordinating regulatory inquiries across global authorities ensuring timely, accurate responses
• Establish and mature operating model for a newly consolidated team
• Drive performance using metrics, dashboards, and reporting mechanisms
• Coordinate cross-functional collaboration with Regulatory Affairs, Legal, Quality, and SMEs
• Communicate progress, risks, and priorities to senior and executive leadership
• Direct reports through goal setting, performance reviews, and coaching
• Organize and facilitate cross-functional meetings and projects
• Own and improve end-to-end regulatory inquiry processes
• Provide executive-level communications and presentations on regulatory activities

Skills

Regulatory Affairs Management

Team Leadership

FDA Knowledge

Lean Six Sigma Black Belt

Process Improvement

Regulatory Reporting

Post‑Market Surveillance

Complaint Handling

Workflow Optimization

Cross‑Functional Collaboration

Stakeholder Management

Presentation Skills

Education

Bachelor’s degree

Advanced degree

Tools

Dashboards

Reporting Mechanisms

Regulatory software

Job description

• Lead a team responsible for coordinating and delivering timely, accurate, and well-supported responses to global regulatory authority inquiries related to post-market quality activities
• Establish and mature the operating model for a newly consolidated team
• Lead approximately seven professionals
• Build team capability, drive role clarity, strengthen execution discipline, and improve timeliness and quality of regulatory responses
• Coordinate cross-functional collaboration with Regulatory Affairs, Legal, Quality, and business-unit subject-matter experts
• Communicate performance, risks, trends, and improvement priorities to senior and executive leadership
• Directly manage professionals through goal setting, performance expectations, work assignment and balancing, employee leveling, performance reviews, coaching, and improvement plans
• Establish, implement, and continuously improve a standardized end-to-end regulatory inquiry operating model
• Drive operational performance using metrics, dashboards, and reporting mechanisms
• Own and evaluate existing processes and implement process improvement initiatives
• Organize, lead, and facilitate cross-functional teams and meetings
• Communicate team progress, including executive leader communications and presentations

Requirements

• Bachelor’s degree and minimum of 5 years relevant experience, or advanced degree with a minimum of 3 years of prior relevant experience
• Minimum of 2 years of prior experience supervising or managing others
• Experience managing new or growing teams
• Knowledge of FDA, EU MDR, and other global regulatory requirements
• Relevant experience in medical device quality, regulatory affairs, post-market surveillance, complaint handling, regulatory reporting, field corrective actions, or related regulated healthcare or life‑sciences environment
• Demonstrated experience leading cross‑functional work in a regulated environment
• Demonstrated experience managing complex work to defined timelines, including issue escalation and stakeholder coordination
• Strong written communication skills, including clear, concise, evidence‑based technical or regulatory communications
• Strong verbal communication, presentation, and stakeholder‑management skills
• Knowledge of Lean Six Sigma Black Belt or similar methodologies
• Ability to deliver executive‑level presentations and communicate complex topics effectively
• Experience implementing process automation, workflow optimization, and technology solutions
• For Baccalaureate degrees earned outside of the United States, a degree satisfying 8 C.F.R. § 214.2(h)(4)(iii)(A) is required
• Roles below the Principal level require unrestricted U.S. work authorization at the time of hire and for the duration of employment

Core Competencies

Demonstrates expertise in managing regulatory inquiries and leading cross‑functional teams within a regulated healthcare environment. Proficient in process improvement, operational performance metrics, and effective communication with executive leadership.

Highest-signal resume keywords

• Regulatory Affairs Management
• Team Leadership
• FDA Knowledge
• Lean Six Sigma Black Belt
• Process Improvement

Hard Skills

• Regulatory Reporting
• Post-Market Surveillance
• Complaint Handling
• Workflow Optimization
• Process Automation

Soft Skills

• Strong Written Communication
• Verbal Communication
• Presentation Skills
• Stakeholder Management

Certifications & Qualifications

• Lean Six Sigma Black Belt

Industry Keywords

• Medical Device Quality
• Global Regulatory Requirements
• EU MDR
• Cross-Functional Collaboration
• Regulated Environment

Tools & Technologies

• Metrics
• Dashboards
• Reporting Mechanisms