Regulated Products Complaint Investigator – Niel

Job Description:
To strengthen our team, we are looking for a Regulated Products Complaint Investigator for the location Niel, Belgium.

Your Responsibilities:

• EU, FDA and ROW Complaint Investigation compliance, health hazard evaluation, medical device reporting, and post market surveillance of human, onco and prenatal next generation sequencing products
• Complaint investigation of assays involves reagents, instruments, primers and software
• Evaluate all incoming complaints (internal or external) to determine level of investigation required and any reporting to regulated bodies and field
• Trend and evaluate systemic issues and perform root cause analysis, corrective actions and preventive action (CAPA) for complaints, as necessary
• Perform health hazard evaluation and risk assessment and determine and document for any recalls, field corrections and medical device reporting
• Develop effective testing parameters to understand the root cause of the complaint using input from the customer and internal SOPs
• Maintain customer complaint documentation including complaint details, product return information as per the regulatory requirements
• Communicate with marketing, R&D and operations personnel during the course of investigation of customer complaints
• Manage interdepartmental / global teams to investigate and correct root cause of all verified complaints through the established CAPA system
• Record complete and accurate findings regarding each complaint investigation, including the conclusion and any corrective action required
• Communicate findings to technical services and management in concise summary formats
• Determine the regulatory reporting requirements for each complaint and prepare the necessary reporting documentation for submission to regulatory agencies. These reports include Medical Device Reports, Vigilance Reports, Canadian Problem Reports, etc.
• Monitor MedWatch for any unreported claims and evaluate the need for investigation
• Track, compile, and report on complaint metrics

Your Profile:

• Bachelors or Master’s degree in Biological Sciences or equivalent (BioInformatics, Chemistry or Bio-Chemistry is a plus)
• 4-5 years of laboratory bench work experience (industry preferred but not required)
• Proficient in Array testing, biological reagent testing, data analysis and work flow troubleshooting including instrumentation, arrays and biological materials
• Familiarity with ISO 13485, ISO 17025 and QSR quality management system requirements and IVD products

We Offer:

• Training and development opportunities.
• A commitment to work/life balance.
• Total Compensation Package including medical and dental benefits, retirement programs and more.
• A company with values around innovation and contribution, uncompromising integrity, trust, respect and teamwork, speed, focus, and accountability.
• The diversity of cultural and individual perspectives held by our employees and their commitment to inclusion.

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Requeriments :

• Technical Bachelor

Areas :

• Bioinformatics

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Additional Info:
Agilent is the premier laboratory partner for a better world. We provide life science, diagnostic and applied market laboratories worldwide with instruments, services, consumables, applications and expertise. Agilent enables customers to gain the insights they seek – so they can do what they do best: improve the world around us. Information about Agilent is available at www.agilent.com.

Multiplicom N.V. (as part of Agilent Technologies) is a Belgian biotech company focused on human molecular diagnostics. The company develops, manufactures and commercializes leading edge and easy-to-use genetic test kits based on the latest molecular diagnostic technologies. With its easy and reliable methodology it is enabling all molecular laboratories the implementation of personalized medicine.

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