The Director, Complaint Handling is responsible for overseeing the entire process of receiving, investigating, resolving and, medical device reporting, and ensuring compliance with all regulatory requirements, identifying trends in complaints, and implementing corrective actions to mitigate risks while maintaining accurate documentation and leading a team of complaint handlers. This position may work REMOTE.

Complaint Intake and Triage:

• Receive and log all incoming medical device complaints from various sources (healthcare providers, patients, distributors). 
• Conduct initial assessment to determine severity and reportability of complaints according to regulatory standards (e.g., FDA, ISO 13485). 
• Assign complaints to appropriate complaint handlers within the team. 

Complaint Investigation:

• Lead the thorough investigation of complaints, including data collection, analysis of device history records, root cause analysis, and communication with relevant stakeholders. 
• Coordinate with cross-functional teams (Laboratory operations, quality assurance, Medical, regulatory legal, clinical affairs) to gather necessary information for investigation. 

Reporting and Documentation:

• Ensure accurate and timely documentation of all complaint details, investigation findings, and corrective actions taken in the complaint management system. 
• Generate comprehensive reports on complaint trends, including analysis of potential safety concerns and areas for improvement. 
• Submit required regulatory reports to relevant agencies (e.g., FDA MedWatch) within established timelines. 
• Partner with cross-functional teams to develop customer communications to address any internal or external customer issues.

Corrective Action Implementation:

• Identify and implement appropriate corrective actions based on complaint analysis to prevent recurrence of issues. 
• Monitor the effectiveness of corrective actions and adjust as needed. 

Program Management/Continuous Improvement and Trend Analysis: 

• Establish, maintain, and continuously improve global complaint handling process, post-market risk assessment field actions, recalls, advisories notices, and adverse events and incident reporting.
• Oversee the global complaint investigations for timely processing and proactive monitoring of product performance. 
• Assures timely complaint initiation, investigation/analysis, reportability assessments, and reporting to appropriate domestic and international governments as required, and complaint closures.​
• Monitor and trend data for CAPA issuance to drive improvements for new failure mode or complaint systemic issue.
• Drive a culture of continuous improvement and operational excellence within the team and the organization.

Risk Identification, Evaluation Assessment, and Trend Analysis:

• Establish a complaint handling risk management process for identifying, evaluating, and mitigating potential risks.
• Conduct complaint risk assessment and generate and maintain complaint risk management files.

Team Leadership and Development:

• Lead, manage, and mentor a team of complaint handlers, providing training, coaching, and performance feedback. 
• Assign workload and prioritize complaints based on severity and regulatory requirements. 
• Foster a culture of quality and compliance within the complaint handling unit. 

Compliance and Quality Assurance:

• Maintain compliance with all applicable regulatory standards related to medical device complaints (e.g., FDA 21 CFR Part 820). 
• Conduct regular audits and reviews of complaint handling processes to identify areas for improvement. 
• Required Skills and Qualifications:
• Bachelor's degree in a related field (e.g., life sciences, engineering, quality assurance).
• Strong understanding of medical device regulations (FDA, ISO 13485).
• Proven experience in complaint handling within the medical device industry.
• Excellent analytical and problem-solving skills
• Strong communication and interpersonal skills to effectively interact with internal and external stakeholders.
• Ability to lead and manage a team.
• Proficiency in complaint management software and data analysis tools
• Support regulatory inspections and audits associated with complaint program.

Other duties as assigned.

QUALIFICATIONS

Required Work Experience: 

• 10+ years of complaint handling in a GXP environment in the Pharmaceutical, Medical Device or Biotech Industry with a strong preference for leadership experience in a functional Quality role.
• A bachelor’s degree in a related field (e.g. Life Sciences, engineering Quality Assurance)
• Strong understanding and application experience of medical device regulations (FDA 21 CFR Part 803, 21 CFR Part 806, 21 CFR Part 820, ISO 13485, ISO 15189, CAP, CLIA).
• Excellent analytical and problem-solving skills. 
• Strong communication and interpersonal skills to effectively interact with internal and external stakeholders.
• Ability to lead, manage, and mentor a team. 
• Proficiency in complaint management software and data analysis tools.

Preferred Work Experience:

• N/A

Physical and Mental Requirements:

• Capability to move around the lab space and various environments including warehouse, laboratory, office.
• Strong attention to detail for thorough analysis of quality data and documentation.
• Excellent problem-solving skits to identify and address quality issues effectively.
• Ability to work under pressure and meet deadlines, maintaining accuracy.
• Strong communication skills to collaborate with various teams and present finding effectively.

Knowledge: 

• Broad based technical knowledge and skills in diverse areas of business such as Quality Engineering, Quality Assurance, Quality Systems, GMP Operations as well as a good working knowledge of related functions such as operations, supplier management, laboratory operations and product development.
• Working knowledge of both FDA 21CFR Part 820 Quality Systems Regulations, ISO13485 standards, and CLIA, CAP, FDA requirements
• Demonstrated knowledge of business impact of compliance issues and risk management.

Skills: 

• Strong working relationships with Operations, Procurement, R&D, Regulatory Affairs, and the broader Global Quality & Compliance organization are necessary to drive effective prioritization and collaboration to meet the needs of the business.
• Possesses strong conflict resolution, change management, communication (written and verbal), organizational management, business ethics and analytical reasoning skills and demonstrates the ability to work in a diverse cross-functional environment.
• Ability to act as technical expert during FDA and other health authority inspections.
• Highly collaborative and leads by example with a servant leadership model.
• Ability and willingness to roll up sleeves and engage to resolve day-to-day issues.

EDUCATION
Bachelor’s Degree(Required)

LICENSECERTIFICATIONS

Equal Opportunity Employer: Race/Color/Sex/Sexual Orientation/Gender Identity/Religion/National Origin/Disability/Vets