Medical Device Complaints Manager

SharkNinja•Needham, MA

About The Position

SharkNinja is a global product design and technology company, with a diversified portfolio of 5-star rated lifestyle solutions that positively impact people’s lives in homes around the world. Powered by two trusted, global brands, Shark and Ninja, the company has a proven track record of bringing disruptive innovation to market and developing one consumer product after another has allowed SharkNinja to enter multiple product categories, driving significant growth and market share gains. Headquartered in Needham, Massachusetts with more than 4,100 associates, the company’s products are sold at key retailers, online and offline, and through distributors around the world. 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.

Requirements

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.

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.