As the Medical Device Complaints Manager, you will lead the design, execution, and continuous improvement of SharkNinja's global medical device complaints and post-market surveillance processes. This role is accountable for ensuring complaints are consistently captured, investigated, trended, and escalated in compliance with global regulatory requirements-while remaining tightly integrated with SharkNinja's customer experience and consumer electronics operating model.
You will establish and operate a complaints process that is risk-based, scalable, and audit-ready, aligned to device classification and global market requirements. Partnering closely with Customer Experience, Core Quality, NPD Quality, Engineering, Regulatory, Legal, and Product teams, you will ensure post-market signals are translated into meaningful corrective actions, risk mitigation, and product improvements-supporting both patient safety and rapid innovation at scale.
Key Responsibilities
• Own and evolve the global medical device complaints and post-market surveillance process, ensuring compliance with 21 CFR Part 820 / FDA QMSR, ISO 13485, EU MDR, and other applicable global requirements. • Design and maintain a risk-based, scalable complaints framework aligned to device classification, product complexity, and SharkNinja's global market footprint. • Oversee complaint intake, triage, investigation, escalation, and closure, ensuring timely, thorough, and compliant handling across all regions. • Lead adverse event assessment and vigilance reporting, including FDA MDRs, EU MDR PMS/Vigilance reporting, and other country-specific submissions as required. • Establish and monitor complaints metrics, trending, and dashboards, identifying systemic issues, emerging risks, and early warning signals. • Ensure complaints data feeds effectively into CAPA, risk management, and product improvement activities, partnering closely with Core Quality, NPD Quality, Engineering, and Product teams. • Coordinate technical investigations and root cause analyses with Core Quality, Engineering, Product Development, and Customer Experience teams. • Lead and support medical device recalls, field actions, and safety communications, and serve as the primary complaints and post-market subject matter expert during audits and regulatory inspections.
Qualifications & Experience
Bachelor's or Master's degree in Engineering, Life Sciences, Quality, Regulatory Affairs, or a related technical discipline.
7-10+ years of experience in medical device complaints handling, post-market surveillance, vigilance, or quality systems, preferably within consumer electronics, electromechanical devices, or high-velocity product environments.
Demonstrated experience designing, operating, and scaling medical device complaints and post-market processes compliant with 21 CFR Part 820 / FDA QMSR, ISO 13485, and EU MDR.
Strong hands-on experience with complaint investigations, adverse event reporting, vigilance submissions, trending, and CAPA integration.
Experience authoring and maintaining EU MDR post-market documentation, including PMS plans/reports and PSURs (as applicable).
Proven experience supporting or leading medical device recalls and field actions, including cross-functional coordination and regulatory communication.
Strong cross-functional influence and communication skills, with the ability to translate post-market data into actionable quality, product, and risk decisions.
Experience managing or leading complaints or post-market teams.
Pragmatic, risk-based mindset with a proven ability to operationalize post-market compliance in fast-paced, consumer-driven environments.