Director, Global Complaint Management

RxSight, Inc.•Aliso Viejo, CA

About The Position

RxSight® is an ophthalmic medical technology corporation headquartered in Aliso Viejo, California that has commercialized the world’s first and only adjustable intraocular lens (IOL) that is customized after cataract surgery. The company’s mission is to revolutionize the premium cataract surgery experience by allowing surgeons to partner with their patients to achieve optimized results for every unique eye. OVERVIEW: The Director of Global Complaint Management leads the company’s global complaint handling and post-market surveillance operations. This role is responsible for ensuring that the complaint system is scalable, compliant with global regulations, and efficient. The Director will act as the primary liaison between RD&E, Quality, Medical Affairs, Manufacturing, and Field Teams to ensure product issues are investigated thoroughly and resolved quickly. As a leader operating largely through influence, this person will drive accountability across the organization to uphold patient safety and product quality standards.

Requirements

Proven ability to lead cross-functional teams and drive results in a matrix environment without relying on direct reporting lines.
Ability to synthesize complex quality data into clear, actionable insights for the internal teams and external auditors.
Demonstrated capability to guide organizations through process changes, system implementations, and shifting regulatory landscapes.
Ability to remain composed and decisive while managing high volumes of data and tight regulatory deadlines.
Demonstrated capability to design, implement, and continuously improve processes that can effectively manage high volumes while maintaining quality and compliance.
Expertise in root cause analysis, CAPA, and risk management methodologies.
Customer-focused mindset with desire to contribute to early recognition of quality trends.
Manage internal and external resources, including but not limited to:
Coordinate and review the work of indirect reports and/or consultants
Monitor and report on performance against established standards identifying training and development opportunities
Provide input on resource allocation decisions
Provide input for indirect report annual performance reviews
Provide technical guidance and/or subject matter expertise
Bachelor’s degree in Engineering, Life Sciences, or a health-related field is required. A Master’s degree is a plus.
Minimum of 7 years of experience in Quality, Post-Market Surveillance, or Regulatory Affairs within the medical device industry. 10+ years of experience is preferred.
Minimum 3 – 5 years of leadership experience specifically managing complaint handling, vigilance, or post-market surveillance activities.
Hands-on experience with global complaint databases, eQMS systems, and vigilance reporting platforms (e.g. TrackWise, MasterControl, ComplianceQuest, Veeva Vault QMS, Greenlight Guru, ETQ)
In-depth knowledge of FDA 21 CFR Part 820, FDA 21 CFR 803, ISO 13485, ISO 14971, EU MDR, MDSAP, and other global complaint reporting requirements including all countries under MDSAP regulation.
Training to be completed per the training plan for this position as maintained in the document control system.
The training requirements on TRN-10007 Insider Trading Policy, TRN-10008 Global Anti-Bribery and Anti-Corruption Policy and TRN-10009 Code of Business Conducts and Ethics must be diligently completed within 30 days from the hiring date and on an annual basis.
Proficient user of basic computer applications for the execution of daily project operations.
Experience with data analysis (Minitab, Python, Matlab) and analytics (e.g. power BI, Tableau) tools.
Experience working with CRM applications (such as Sales Force) and integrating with legacy systems is preferred.

Responsibilities

Develop and implement a robust, scalable global complaint handling strategy that supports current operations and accommodates future market expansion and regulatory changes.
Continuously refine workflows for intake, triage, investigation, and closure to maximize efficiency without compromising compliance rigor.
Lead the selection and implementation of best-in-class digital tools (eQMS, AI-driven analytics) to automate routine tasks and streamline vigilance reporting.
Adapt complaint handling resources and processes to support business growth and new product launches without sacrificing compliance.
Ensure accurate, timely, and complete decision-making for Medical Device Reporting (MDR), vigilance reports, and other global regulatory submissions.
Serve as the Subject Matter Expert (SME) for complaint handling during audits and inspections (FDA, Notified Bodies, MDSAP).
Monitor global regulatory changes and update internal procedures to remain compliant with evolving standards (e.g., FDA, EU MDR, ISO).
Facilitate seamless communication between RD&E, Manufacturing, R&D, Medical Affairs, and Field Teams to ensure investigations are complete and well-documented.
Integrate complaint data into the company’s Post-Market Surveillance system to inform and Risk Management files and Clinical Evaluation Reports, ensuring compliance with international regulations and standards (e.g., FDA, EU MDR, ISO 13485, ISO 14971).
Establish clear roles and responsibilities for all departments involved in the complaint process and provide ongoing training to ensure alignment.
Establish and monitor Key Performance Indicators (KPIs) regarding timeliness, closure rates, and investigation quality; present trends to Senior Leadership during Management Reviews.
Analyze complex data sets to identify early warning signs of emerging product or process issues, driving proactive risk mitigation.
Promote a culture of quality, accountability, and continuous improvement across all complaint handling departments.