JOB DESCRIPTION:

MAIN PURPOSE OF ROLE
• Product Surveillance Analyst is responsible for Medical Device Report (MDR) submission documentation and follow-ups, and
will include interaction with Complaint Coordinators, Failure Analysis, Servicing, Customer Service, etc.
• Performs all activities pertaining to receiving and investigating reports of worldwide complaints/events on a variety of
products; entering information into the complaint database; independently determining and filing appropriate medical devices
reports with various regulatory agencies; participating on cross functional teams; and providing information on product
complaints to various teams (e.g. Regulatory, Quality Engineering).
• Analyzes and resolves customers technical and clinical questions regarding company products.
• Corresponds with customers regarding the results of inquiries and analysis of products.
• Uses discretion in escalating unusual product performance issues, collaborates with engineering, resolves customer
complaints.
• Participates in product improvement teams, field failure analysis and other analytical teams responsible for the
improvement of products and regulatory issues.
• This position requires a very high degree of technical competence and communicative ability in order to receive, evaluate,
investigate and respond to customers' questions and complaints.

MAIN RESPONSIBILITIES
• Interfaces with all levels of health care professionals (doctors, nurses, biomedical technicians and purchasing agents,
materials managers and risk managers) to document, investigate, and correct field-related problems.
• Manage, maintain, and track customer complaints through the Quality Systems Database in accordance with Site
procedures and regulatory agencies, specifically, 21 CFR Part 820, Complaint Files, and 21 CFR Part 803, Medical Device
Reporting
• Complies with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, Company policies,
operating procedures, processes, and task assignments. Maintains positive and cooperative communications and
collaboration with all levels of employees, customers, contractors, and vendors.
• Communicates customer concerns and complaints to individuals who manage databases and analyze data to identify
trends, needs for product and service enhancements and communicate the findings with relevant individuals such as R&D
engineers, business unit managers, and other personnel to communicate the
• findings.
• Strong multitasking skills. Performs product complaint documentation, investigation, customer response, and consulting
activities on company products and authors correspondence to customers addressing complaint investigations.
• Serves as a liaison between other business units for quality and technical concerns as needed.

QUALIFICATIONS
Education
Bachelor's Degree, Post Graduate
Diploma, Professional Degree,
preferable in Clinical / Medical /
Scientific discipline or equivalent.

☐Experience/Background
• Knowledge in Medical Terminology is fundamental to the role.
• Average of 1-2 years in customer support or complaint handling experience would be advantage to this position.
• Strong PC/Data Entry Skills required.
• A high degree of interpersonal relations skills, with strong verbal and written communication skills in English language.
• Good Problem-Solving Skills: Must be able to work under pressure and stress common to office environments; maintain a high degree of accuracy and analytical thinking; and with ability to deal effectively with problems and customers on the telephone.

The base pay for this position is

N/A

In specific locations, the pay range may vary from the range posted.

JOB FAMILY:

Operations Quality

CRM Cardiac Rhythm Management

Malaysia > Penang : Plot 102, Lebuhraya Kampong Jawa Bayan Lepas Industrial Zone 11900

Standard

Yes, 5 % of the Time

Not Applicable

Not Applicable