Medical Device Complaints Manager

About Us

SharkNinjais a global product design and technology company with a diversified portfolio of 5-star rated lifestyle solutions that positivelyimpactpeoples lives in homes around the world. Powered by two trusted global brands Shark and Ninja the company has a proventrack recordof bringing disruptive innovation to market and developing one consumer product after another has allowedSharkNinjato enter multiple product categories driving significant growth and market share gains. Headquartered in Needham Massachusetts with more than4100associates the companys 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 ofSharkNinjasglobal 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 requirementswhileremainingtightly integrated withSharkNinjascustomer experience and consumer electronics operating model.

You willestablishand operate acomplaintsprocess 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 improvementssupporting 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 andmaintaina risk-based scalable complaints framework aligned to device classification product complexity andSharkNinjasglobal market footprint.

• Oversee complaint intake triage investigation escalation and closure ensuringtimely 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 asrequired.

• Establish andmonitorcomplaintsmetrics trending and dashboardsidentifyingsystemic 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

• Bachelors orMasters degree in Engineering Life Sciences Quality Regulatory Affairs ora relatedtechnical discipline.

• 710 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 designingoperating 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 andmaintainingEU 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.