Customer Quality Regulatory Inquiry Manager

• 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

• 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

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.

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

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

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

• Lean Six Sigma Black Belt

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

• Metrics
• Dashboards
• Reporting Mechanisms