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Complaints Analyst I, CS Team - NY, NJ & CT (REMOTE)

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Date: Jan 14, 2022

Location: Wayne, NJ, US

Company: Getinge

 

Together we can make a difference

At Getinge we are dedicated and passionate about helping our customers save lives and ensure excellent care. We provide innovations for operating rooms, intensive-care units, sterilization departments and for life science companies and institutions. Our portfolio combines well-known product brands such as Maquet, Pulsion, Atrium, Lancer and Datascope – just to name a few.

A career at Getinge will provide career opportunities that both inspire and challenge. Here, you can make a difference every day.

 

At Getinge we are dedicated and passionate about helping our customers save lives and ensure excellent care. We provide innovations for operating rooms, intensive-care units, sterilization departments and for life science companies and institutions. Our portfolio combines well-known product brands such as Maquet, Pulsion, Atrium, Lancer and Datascope – just to name a few.

A career at Getinge will provide career opportunities that both inspire and challenge. Here, you can make a difference every day.

 

We have an opening for a Complaints Analyst I. This position supports and provides assistance in the evaluation of Product Complaints for Medical Device Reporting (MDR) and Vigilance (MDV) reports. This position is responsible for reporting of complaints and processing of trend analysis in accordance with department procedures and applicable regulatory requirements. Work closely with members of Sales and Servicing Unit (SSU), Engineering, Marketing, Medical, Regulatory, and Quality departments. May interact with external customers, hospital staff, and/or other external personnel as required.

 

 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:

  • 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.
  • Critical thinking skills - the ability to analyze information objectively and make a reasoned judgment.
  • Analytical skills - 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.
  • 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.
  • Ability to communicate clearly and concisely (written and oral), including technical writing skills.

#LI - MM1

#LI-REMOTE

 

We look forward to receiving your application. If you share our passion and believe that saving lives is the greatest job in the world, then we look forward to receiving your application. We hope you will join us on our journey to become the world’s most desired medtech company.

 


Nearest Major Market: New Jersey