Job Description

This position is responsible for processing and coordinating the review of medical device complaints in accordance with requirements from Health Canada and enable Olympus to investigate and report to applicable international regulatory bodies. The individual will support the continuous improvement efforts of the Quality System for processing complaints in order to meet Health Canada, FDA, ISO and all applicable international regulatory requirements and corporate guidelines.

The individual will support pre-market licensing activities including registrations, renewals, and maintenance activities in accordance with the Canadian Medical Device Regulations to support business goals as assigned. Performs special assignments upon request.

Job Duties

• Enters and process complaint information received from internal and external sources into complaint handling databases as appropriate. Interface with internal and external customers to obtain additional information to facilitate complaint investigation by the manufacturer. Documents all communication in compliance with department procedures.

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  Coordinates with internal and external customers, such as Operations, Service and international Olympus personnel, to support timely failure investigation.

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  Evaluate complaints against Mandatory Problem Reporting requirements to Health Canada and other applicable regulatory agencies. Prepare and submits Mandatory Problem Reports for review in a timely manner. Files Preliminary and Final MPRs with Health Canada.

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  Monitor and prepare work in progress reports and key performance indicators regularly.

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  Manage and update complaints throughout file lifecycle. Document applicable elements of the complaint handling process, such as contact records with external customers, database updates, and complaint closure letters.

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  Occasionally interface with Health Canada and other regulatory agencies regarding complaints.

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  Improves the complaint handling process and routine tasks for better efficiency and greater integrity.

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  Support timely processing of Product Change Management, MDL/MDEL registrations, renewals, license maintenance, and product review/setups to support business goals as assigned.

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  Support and maintain the Quality Management System at Olympus Corporations of the Americas.

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  Provide support, when required, to run training reports and prepare status updates related to various Regulatory Affairs and Quality Assurance activities.

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  Occasionally support document management and filing of complaint records and product licensing submissions. Responsible for managing and processing LCRs (Labelling Change Requests) throughout the lifecycle of labeling materials, including initiation, preparation, review, approval, closure, and release.

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  Perform all other duties as directed

Job Requirements

REQUIRED QUALIFICATIONS:

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  Post secondary education in Scientific, Clinical, Biomedical, or Engineering discipline, or equivalent knowledge.

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  Minimum 2 years of experience within Medical Device, Pharmaceutical or Hospital environment, with strong concentration in compliance and/or Quality Assurance preferred.

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  Capable of working independently with general instructions from manager while following SOP, corporate policies and regulatory requirements.

PREFERRED QUALIFICATIONS:

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  Bilingual English-French in speaking reading writing abilities.

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  Strong analytical, organizational and communication skills required.

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  Must be able to multitask and meet deadlines on multiple projects.

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  Strong attention to detail and accuracy are required.

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  Must be able to demonstrate a working proficiency in operating a personal computer and perform basic word processing spreadsheet tasks using Microsoft Excel and Word applications.

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  Knowledge of Canadian Medical Devices Regulation, FDA Quality System Regulations and ISO 13485 preferred.

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  Knowledge of Global Enterprise Complaint Handling/Quality Management Systems (EtQ, Trackwise, etc) is preferred.