Sign up  

Manager, Complaint Handling

Company Name: Hycor Biomedical
Location: Garden Grove, CA
Job Type: Full time
Contact Name: Lizelle Cristobal
Phone: 714-933-3046
Fax:
Email: Email your resume directly to Lizelle Cristobal at This email address is being protected from spambots. You need JavaScript enabled to view it.
Salary: DOE

Job Description

Hycor Biomedical is seeking a Manager, Complaint Handling to join our Regulatory Affairs team. For more information about the company please visit: www.hycorbiomedical.com   

Job Duties:

  • Responsible for day-to-day complaint processing at multiple company locations in the US and EU.
  • Perform reportability determinations in conjunction with medical advisor as necessary.
  • Lead Complaint Handling Unit and cross functional team through completion of investigation and closure of reportable and non-reportable product complaints in accordance with established company procedures and worldwide regulations and standards.
  • The role requires approval of complaint investigations, escalation of trends and product problems, and awareness of new or revised regulations and/or guidelines.
  • The Manager will drive continuous improvement through corrective and preventive action processes, lead continuous improvement activities, and provide subject matter expertise on complaint handling requirements. Reviews and continuously leads efforts to improve the global complaint handling and post market surveillance processes.
  • Serve as a subject matter expert (SME) for complaint processing, complaint investigation and MDR reporting during audits and inspections.
  • Provides management direction, motivation, and support for personnel.


Job Requirements

Skills and Knowledge:

  • Bachelor's degree in Science or Engineering or related technical field or equivalent experience is required
  • 8+ years of related experience, including significant experience working in in vitro diagnostics, medical device or another highly regulated industry.
  • 2+ years of experience leading people and running projects is required.

Email your resume directly to Lizelle Cristobal at This email address is being protected from spambots. You need JavaScript enabled to view it.