Manager, Post Market Surveillance

A global eye care leader, CIBA Vision has one of the most exciting product pipelines in the industry today. A pipeline of innovative contact lenses and lens care products brought to life by diverse, talented, performance driven people who share a passion for healthy vision and better life. All of which makes us one of the most rewarding employers in our field.How do you spend your day? Are you passionate about what you do? At CIBA Vision, our focus is clear, our purpose defined. We're part of a team that's making a difference in the quality of people's lives.Think what's possible. This position manages the Global Complaint Management, Medical Device Reporting and Risk Management processes and staff, and is responsible for providing training, support & monitoring the functions & representatives (Sales, Distributors, Manufacturing Sites, Professional & Customer Service, etc.) worldwide to assure accurate & immediate reporting, effective investigations, proper analysis, timely filing of Adverse Events and compliance with international (e.g. FDA, ISO), regional (e.g. MDD) & country (e.g. France, Japan) regulations. Leads the organization to proactively identify critical complaints, potential major risks, negative trends & product problems to alert management to major quality problems, potential systemic issues and needed product & processes improvements. Implements and deploys advanced IT solutions to significantly improve the effectiveness, efficiency & reliability of these quality systems as well as the communication of key information.Primary Responsibilities:- Manages the Global Complaint Management (GCM) process, Medical Device Reporing (MDR) processes and organization including internaional customer service representatives, product verification centers, and responsible quality personnel.- Assures accurate and timely reporting, effective investigations, proper follow-up and analysis by all constituents involved in the processes.- Communicates and initiates investigation into adverse events, potentially significant complaints, major risks and unfavorable changes in trends.- Manages CIBA Vision's Risk Management Process.- Lead continuous improvements & enhancements to both the overall process & the GCM System.- Nurture, Grow & Develop People.QualificationsMinimum Education Required:- BS/BA in Science or Health related discipline Preferred Level:- Advanced degree in Science or Health related disciplineMinimum Experience Required:- 3-5 years experience in a GMP/Healthcare Industry- 2-3 years of Complaint Management experience- 2 years of Management experience - Solid understanding of Medical Device or Pharmaceutical regulations Preferred Level:- 5-8 yrs in a GMP/Healthcare Industry- Several yrs in Medical Device or Product Dev., Manufacturing or Professional/Customer ServiceMinimum Skills Required:- Strong leadership/management skills for a high performance team- Superior written & verbal communications- Superior computer application skills- Ability to develop plans to achieve goals & objectives and significantly improve effectiveness & efficiency of operations- Basic understanding of physiology & medical terminology- Basic understanding of database management- Creative & innovative thinking with respect to problem solving, responding to challenging regulatory situations Preferred Level:- International experience- Applied knowledge & experience with statistical applications.- Good to advanced understanding of eye physiology & ophthalmologic terms
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