Medical Device Complaints Manager

SharkNinjaoperatingllc

Needham, MA, United States
**
Global medical device complaints management
21 cfr part 820 fda qmsr compliance
Iso 13485 and eu mdr regulatory knowledge
** SharkNinja is seeking a Medical Device Complaints Manager to oversee the global complaints and post-market surveillance processes for their medical devices. The role requires compliance with regulatory standards and aims to ensure product improvement and patient safety. **

Job Summary

  • This role is accountable for ensuring complaints are consistently captured, investigated, trended, and escalated in compliance with global regulatory requirements.
  • You will establish a risk-based, scalable complaints process aligned to device classification and global market requirements while partnering closely with multiple internal teams.
  • The position requires leading adverse event assessments and vigilance reporting including FDA MDRs and EU MDR submissions to support patient safety.

Matching Summary

Match Score: 75

** SharkNinja is seeking a Medical Device Complaints Manager to oversee the global complaints and post-market surveillance processes for their medical devices. The role requires compliance with regulatory standards and aims to ensure product improvement and patient safety. **

Skills & Requirements

Must-have

  • Global medical device complaints management
  • 21 CFR Part 820 FDA QMSR compliance
  • ISO 13485 and EU MDR regulatory knowledge
  • Adverse event assessment and vigilance reporting
  • Root cause analysis and CAPA coordination
  • Risk-based complaint framework design

Nice-to-have

  • Experience in consumer electronics operating model
  • Strong partnership with Customer Experience teams
  • Ability to drive rapid innovation at scale
  • Cross-functional leadership skills

Key Requirements

  • Knowledge of 21 CFR Part 820 / FDA QMSR
  • Understanding of ISO 13485 standards
  • Familiarity with EU MDR regulations
  • Experience with FDA MDR and PMS/Vigilance reporting

Work Rights

Not specified

Tailored Resume

Cover Letter