Complaints Manager

2 days ago


Miami, Florida, United States Katalyst HealthCares & Life Sciences Full time
Job Description:

We are seeking a highly experienced Complaints Manager to join our team at Katalyst HealthCares & Life Sciences. The ideal candidate will have a strong background in managing complaints systems, particularly for Class II medical devices. This role is a great opportunity for someone who enjoys working in a fast-paced environment and is passionate about ensuring the highest quality standards.

Responsibilities:
  • Manage the entire complaints system for Class II medical devices, ensuring compliance with regulatory requirements.
  • Work closely with the post-market quality team to handle and report complaints in a timely and efficient manner.
  • Develop and implement effective procedures for handling and resolving complaints.
  • Collaborate with cross-functional teams to ensure seamless complaint handling and reporting.

Requirements:
  • Minimum of + years' experience in managing complaints systems, preferably in the medical device industry.
  • Strong knowledge of FDA regulations and guidelines.
  • Excellent communication and problem-solving skills.
  • Ability to work in a team environment and collaborate with cross-functional teams.

Working Conditions:
  • Complaints are handled electronically using JIRA (Plus).
  • Relatively low volume of complaints, with ~ complaints per month.

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