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 crossfunctional 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.

• Ensures accurate department procedures and work instructions are maintained

• Train new employees to the complaint handling process

• Provide support to the Legal Department regarding product complaints

• Participates in cross-functional complaint review groups on a regular basis or as requested (e.g. crossfunctional complaint teams, new product teams, risk management meetings

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 3-5 years in customer support 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.