Product Surveillance Analyst

Abbott Penang (Formerly Known as St. Jude Medical); George Town; On-site; MYR 30,000 - 45,000; Full time

Job summary

A leading company in the medical field is seeking a dedicated professional to manage product complaints and ensure compliance with regulatory standards. The ideal candidate will possess strong communication skills and a background in healthcare, with the ability to work independently and manage multiple priorities effectively.

Qualifications

• 1-2 years of experience in customer support or complaint handling preferred.
• Proficiency in medical terminologies is advantageous.

Responsibilities

• Comply with FDA regulations and company policies.
• Initiate and manage product complaint files.
• Communicate with stakeholders regarding product complaints.

Skills

Communication

Problem Solving

Organizational Skills

Attention to Detail

Education

Bachelor's Degree in Healthcare

Post Graduate Diploma

Professional Degree

Tools

MS Office

Job description

This job description provides a comprehensive overview of the responsibilities and requirements for the role. However, it can be improved for clarity and professionalism by restructuring some sections and removing repetitive content. Here's a refined version:

Job Responsibilities

1. Comply with U.S. Food and Drug Administration (FDA) regulations, company policies, standard operating procedures, and other regulatory requirements.
2. Initiate and manage product complaint files until record closure.
3. Maintain accurate entries of product complaints in the complaint management system.
4. Communicate verbally and in writing with internal and external stakeholders, including healthcare professionals, technical services, and sales representatives, regarding product complaints.
5. Assess complaint decisions independently and accurately record complaint and non-complaint events.
6. Support the Quality Management System (QMS), Environmental Management System (EMS), and other regulatory requirements on a global scale.
7. Perform desk-based tasks involving computer monitor usage.

Candidate Requirements

• Bachelor's Degree, Post Graduate Diploma, or Professional Degree, preferably in healthcare.
• 1-2 years of experience in customer support or complaint handling preferred.
• Proficiency in medical terminologies is advantageous; experience with Quality Systems and Medical Devices is preferred.
• Ability to work independently with minimal supervision, self-learn, and seek solutions proactively.
• Capable of managing multiple priorities and collaborating with peers and teams.
• Proficiency in MS Office and data entry.
• Excellent interpersonal, verbal, and written communication skills in English.
• Strong organizational, follow-up, and attention to detail skills.
• Reliable attendance and good problem-solving and analytical abilities.