DarioHealth Published: September 20, 2019
Job Type
Level of education
Vocational qualification
Spoken Language needed
Hebrew, English
Level of Hebrew
Medium
Location of job
Netanya
How many relevant years experience do you require for the role:
1 year

Description

The Complaint Coordinator is responsible for the ongoing administration, supervision and continuous improvement of Regulatory, Clinical and Quality systems to ensure compliance with US, Europe, Canada, Australia, and other international complaint handling/device reporting requirements.

- Responsible for receiving, documenting and coordinating investigation on product complaints.
- Ensure timely investigation of product complaints. This involves initiating, participating and documenting investigations and corrective action arising from products complaints.
- Responsible to review, analyze, summarize and interpret data; draw conclusions and make recommendations and decisions regarding complaint investigations.
- Collaborates with Sales personnel, Customer service, Engineering, Manufacturing, Quality Assurance, Clinical Affairs, EU Authorized Representative, Distributors and 3rd Parties in these investigations.
- Maintains current and complete complaint files.

Requirements

- Student in health science discipline or related area.
- Strong communication, organizational and time-management skills required.
- Excellent computer and presentation skills including Microsoft Word, Excel, PowerPoint and Adobe Acrobat.
- Ability to work cross-functionally to resolve issues in a timely manner.
- Fluent in written and spoken English
- Experience in Medical Device industry / Healthcare organizations or related industry – advantage.
- Experience in complaint handling per 21 CFR Part 820 and ISO 13485 is preferred - advantage.
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