Director, Global Complaint Management

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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.

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.

• 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.

• 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 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…