Description de l'emploi
Within our Quality, Regulatory and Safety Department, The Complaint & Vigilance associate is responsible for developing and maintaining efficient complaint handling and vigilance processes within the whole IBA MAS organization.
Responsibilities and duties
•Collect and review complaints
•Ensure follow up of complaints. Collaborate with the whole organization and ensure leadership regarding action plan where needed. Identify safety issues to be escalated to management
•Prepare complaint feedback report if deemed necessary with support of other departments.
•Provide reporting assessment for complaints and output of trends in complaints and incidents to determine and document the need to report to competent authorities based on regulations and risk assessment. Prepare and submit the report to competent authorities in a timely manner. Follow up implementation of corrective and preventive actions until report final closure
•Maintain compliance of procedures to regulations related to complaint handling and update it based on information received from regulatory watch.
•Provide training, when needed, on complaint handling, medical device reporting and post market vigilance
Education and Experience Requirements:
•Master's degree in a scientific or health related field
•A previous experience within Medical Devices or pharmaceutical industry is a plus.
•A good knowledge of Microsoft Office such as Word, Excel and PowerPoint
Key competencies•Communication skills: Good oral and written communications with ability to present data to all levels of audiences
•Productivity/Organizing/Planning skills– you are able to meet deadlines, demonstrates effective use of time, and to handle multiple assignments simultaneously
•Collaboration & Teamwork skills – You are able to work in autonomy as well as in a multidisciplinary environment
•Good English knowledge mandatory
公司IBA : opening new ways in the fight against cancer.
IBA is a cancer diagnostics and treatment company and the worldwide technology leader in the field of proton therapy. The Company’s expertise lies in the development of next generation proton therapy technologies and radiopharmaceuticals that provide oncology care providers with premium quality services and equipment, including IBA’s leading fully integrated IntegraLab® radiopharmacy system, and Dosimetry advanced solutions for Quality Assurance of medical equipment and increased patient safety.
Headquartered in Belgium and employing more than 1,500 people worldwide, IBA currently has installed systems across Europe and the US and is expanding into emerging markets.
The Company is focused on providing solutions in the fight against cancer.
聘用意向书The identity of IBA is characterized by a group of colleagues driven by motivation, curiosity, creativity, the desire to learn on a daily basis, by technical challenges and above all by a highly developed team and family spirit that makes the daily life smoother and more enjoyable!
By joining a team of about 40 nationalities and working on more than 45 different sites on 3 continents, IBA offers you the opportunity of a meaningful career with a direct impact in the fight against cancer.
We are driven by:
- Innovating in a cutting-edge technology environment
- Developing professional and personal skills by learning on the Job; by participating in challenging projects; top class courses
- Evolving in a friendly culture environment based upon solid values (dare - share - care - be fair)
- Acting autonomously and belonging to motivated teams with good work-life balance
- Contributing to a company where sustainability, safety and well-being are key to our success