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Administrative assistant regulatory compliance

Intelerad

This is a Full-time position in Montreal, QC posted August 17, 2019.

Company DescriptionBecome part of our growing community of bright, motivated people who are dedicated and inspired by what they do best.

Principled, honest, and supremely attentive are qualities that set us apart and guide our decisions, every day.

Our creative approach to technology continuously breaks new ground so that our customers can do more.

Solving problems and revolutionizing healthcare is the reason Intelerad was founded.

For almost 20 years, Intelerad has grown into a leader of the medical imaging software industry.

We take pride in being a world-class healthcare solutions company with almost 400 employees and over 1000 customer sites.

Today, our distributed solutions play a vital role in the delivery of healthcare across 11 time zones, 3 continents, and counting.

We provide a workplace that encourages teamwork, promotes well-being, autonomy, and creativity.

We are Intelerad.

Join us if you care to make a difference in healthcare.Job DescriptionAs an Administrative Assistant Regulatory Compliance you will assist the QMS Manager to maintain the Quality Management System (QMS) and the Information Security Management System (ISMS) in compliance with applicable standards and regulatory requirements.

This is a contractual position ( 6 months) based in our downtown office at Place Dupuis (Berri-UQAM metro station).QualificationsResponsibilities As an Administrative Assistant Regulatory Compliance your role will include the following: Ensure corrective and preventive actions are issued, implemented, verified and closed within set timeframes;Manage QMS, ISMS and technical documentation and ensure proper retention of records and documents;Ensure maintenance of the technical dossier (Design History File and Device Master Record) for each software branch;Create, update, and/or review QMS and ISMS related documents, in collaboration with process owners;Organize internal and external audits for QMS and ISMS;Produce various reports and statistics required by the regulatory authorities and communicate safety notifications to clients;Prepare regulatory submission dossiers.Work on special projects with regards to organization’s orientations (reports, statistics, research, etc.).

Pre-requisites College degree in documentation technique or medical records or similar diploma;A minimum of 1 year of practical experience with a Quality Management System;Advanced knowledge of Microsoft Office applications, especially Word and Excel;Practical experience within a software development company.

Additional InformationPersonal competencies Capacity to work both independently and in a team-oriented environment;Ability to effectively complete the tasks entrusted;Capacity to easily adapt to changing priorities and timelines;Strong communication skills in English and French (oral and written);Ability to learn quickly and attention to detail.

Optional competencies Practical experience in a regulated industry;Knowledge of international standards such as ISO 13485, ISO 9001 or ISO 27001;Knowledge of regulatory requirements related to medical devices (Health Canada, FDA, TGA, Medsafe, etc.).