Posted in Compliance 30+ days ago.
Type: Full Time
Job Functions:
* Work in a team environment with members of the SSU and QA-Product Surveillance groups on receiving complaints in the complaint system.
* Work in a team environment with members of the Engineering and Medical teams on completion of Decision Tree (DT) and completion / submission of Initial MDRs.
* Work independently and with different parts of the organization/departments to perform Good Faith Effort (GFE) to obtain required / additional event information and request sample return.
* Ensure complaints are handled in compliance with applicable regulations and regulatory standards.
* Accountable for compliance with all Food & Drug Administration (FDA) and European Union Medical Device Directives (MDD) regulations governing adverse event reports such as Medical Device Reports (MDR) and Medical Device Vigilance (MDV) and reportability requirements for various countries.
Required Knowledge, Skills and Abilities:
* Knowledge of working with quality systems per 21 CFR 820, 21 CFR 803, ISO 13485 is preferred.
* Knowledge in record keeping, computer software, and procedures related to Complaint-Handling and MDR/vigilance reporting in accordance with all applicable regulations is preferred.
Minimum Requirements:
* High School degree or equivalent required. A Bachelor's degree in a Science or related technical field is preferred.
* A minimum of 2-3 years in medical device or other regulated environment is preferred. College degrees can substitute for years of experience.
* Ability to communicate clearly and concisely (written and oral), including technical writing skills.
* Proficiency with Microsoft Office Word, Excel, Visio, Power Point, or equivalent software applications is required.
* Critical thinking - the ability to analyze information objectively and make a reasoned judgment.
* Analytical - the ability to carefully examine something, whether it is a problem, a set of data and then understand what it means or what it represents.
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Getinge is an equal opportunity employer M/F/Veteran/Disability
All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability or protected veteran status