Senior Manager, Complaint & Post-Market Compliance

KLS Martin Group; Jacksonville (FL); Sur place; USD 120 000 - 150 000; Plein temps

Résumé du poste

KLS Martin Group in Jacksonville, FL seeks a Manager, Complaint Management and Post-Market Compliance to lead strategic, regulatory, and operational efforts for capturing, investigating, and reporting complaints across the medical device lifecycle.

The role oversees MDR, post-market surveillance, and field actions, guiding a team of specialists and ensuring timely, compliant outcomes with cross-functional partners and regulators.

Qualifications

• Bachelor's degree in life sciences, engineering, nursing, quality, regulatory affairs, or related discipline.
• Minimum 8 years of progressive medical device experience, including substantial direct experience in complaint handling, post-market surveillance or related regulatory functions.
• Minimum of 3 years of direct people leadership, preferably with responsibility for a complaint, post-market, vigilance, or regulatory organization.
• Demonstrated experience making or overseeing complex reportability determinations and documenting and defending decisions during inspections, audits, or regulatory inquiries.
• Demonstrated success improving complaint throughput, workload visibility, aging, backlog, process efficiency, or cross-functional investigation performance.
• Expert working knowledge of FDA QMSR and ISO 13485, 21 CFR Parts 803 and 806, complaint handling, risk management, field actions and recalls, and applicable global vigilance requirements.

Responsabilités

• Provide strategic leadership for complaint management and post-market activities.
• Oversee intake, investigation, reportability assessment, escalation, documentation, and closure with compliance.
• Lead inspection readiness and responses to regulatory inquiries, audits, and field actions.
• Coordinate corrections, removals, recalls, and associated regulatory notifications.
• Develop and optimize the complaint organization to reduce backlog and improve process efficiency.

Connaissances

Strategic leadership

Regulatory compliance

Complaint management

Risk assessment

Cross-functional leadership

Data analysis

Project management

Communication

Formation

Bachelor's degree in life sciences, engineering, nursing, quality, regulatory affairs, or related discipline

Outils

Microsoft Excel

Description du poste

KLS Martin Group in Jacksonville, FL seeks a Manager, Complaint Management and Post-Market Compliance to lead strategic, regulatory, and operational efforts for capturing, investigating, and reporting complaints across the medical device lifecycle.

The role oversees MDR, post-market surveillance, and field actions, guiding a team of specialists and ensuring timely, compliant outcomes with cross-functional partners and regulators.