Advisor, Regulatory Licensing

Contenuto del lavoro

The individual is responsible for the management of licensing activities and the execution of all the necessary tasks associated with the various regulations to obtain the licenses, which includes the review, the evaluation, the preparation, the coordination, the submission and any follow-up.

What you will do

• Manage and maintain the regulatory status of Roche Diabetes Care Canada by preparing highly technical and scientific documents that are required to support our licensing activities (Class II and III) for new and amended medical instruments. Prepare responses to requests for additional technical information that are frequently asked by Health Canada concerning our license applications or amendments. Review and approve all promotional material and applicable internal and external presentations to ensure compliance with applicable regulations and guidance documents.

• Request and review the regulatory documentation for Class II and III medical devices from Roche Manufacturing Centers globally. Review and approve labeling for all Roche Diabetes Care Medical Devices to ensure that it meets the Canadian Regulatory requirements.

• Maintain an excellent relationship with the Canadian local regulatory agencies and with Roche regulatory colleagues. Review all existing and new Federal policies regarding the licensing processes and ensure that all internal processes related to these activities are kept compliant with the regulations. Inform Marketing /Product Managers on the internal regulatory processes to be followed prior to launching a medical device in Canada and determine the classification, license type and other specifications for each product based upon the Canadian Medical Devices Regulations.

• Perform other tasks such as verify the content of every CMDCAS ISO 13485 Certificate that is issued to Roche Manufacturing Centers, manage the review and record of medical device Labelling Change Notifications (LCN’s) from Roche Manufacturing Centers and other contacts. Assess if Class III medical device LCN’s are classified as significant changes.

• Perform regulatory compliance and quality assurance related tasks.

Pre-requisites

• Bachelor degree in Science or a minimum of 10 years’ experience in a scientific background position;

• 5-7years of experience in similar role;

• Excellent knowledge of the Canadian Medical Devices Regulations;

• Motivated, self-empowered, great team player and passionate about improving the life of patients;

• Fluent in French and English , written / spoken.