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Full-Time

Sr. Complaints Specialist

Confirmed live in the last 24 hours

Element Science

Element Science

51-200 employees

Develops wearable cardioverter defibrillators

Data & Analytics
Hardware

Compensation Overview

$100k - $115kAnnually

+ Stock Options

Senior

San Carlos, CA, USA

Category
Healthcare Administration & Support
Nursing & Allied Health Professionals
Medical, Clinical & Veterinary
Required Skills
Communications
Management
Requirements
  • Bachelor's degree in a scientific or engineering discipline
  • 7+ years experience in the medical device industry with 4+ years experience in the complaint handling process
  • Previous experience with MDR Reporting via FDA portal
  • Knowledge of FDA 21 CFR 820,21 CFR 803, and ISO 13485
  • Experience working in the medical device industry, preferably Class III
  • Strong communication and organizational skills required
  • Accuracy, attention to detail, and thoroughness
  • Proficiency required with Microsoft applications
Responsibilities
  • Act as the complaint lead to oversee the complaint handling, MDR reporting, and EU Vigilance processes
  • Leads complaint activities and guides effective complaint analysis promptly
  • Responsible for oversight and training of Complaint Specialists, including assignment of complaint-related tasks
  • Lead MDR Committee for reportable events and completes Health Hazard Evaluation (HHE) and Health Risk Assessment (HRAs) in a timely manner
  • Coordinate the oversight of complaint-related tasks assigned to areas outside of the complaint group
  • Lead meetings with appropriate departments for specific customer complaint issues, determination, and resolution of root causes for complaints
  • Provide leadership and guidance when necessary to ensure issues are being addressed and escalated promptly
  • Provide analysis of complaint data/trends and identify potential corrective or preventive actions
  • Identify and implement efficiency and compliance improvements to the complaint management process
  • Responsible for ensuring complaint files are addressed and comply with regulatory requirements for complaint management
  • Other tasks as assigned by the management

Element Science is at the forefront of medical technology with its development of the Jewel Patch Wearable Cardioverter Defibrillator, a device designed to treat life-threatening heart rhythms. This commitment to creating cutting-edge, life-saving technology not only reflects an innovative approach to tackling cardiac conditions but also demonstrates a deep commitment to improving patient outcomes. Working here means being part of a dedicated team that's shaping the future of heart disease treatment, backed by advanced detection technologies and a focus on significant health challenges.

Company Stage

Series C

Total Funding

$183.1M

Headquarters

San Francisco, California

Founded

2013

Growth & Insights
Headcount

6 month growth

6%

1 year growth

10%

2 year growth

43%