Regulatory Affairs Specialist

Reporting to the Manager Regulatory affairs, the Specialist, Regulatory Affairs will evaluates, develops and recommend submission pathways, options and strategies for departmental assignments.  He/She will prepare the various medical devices applications, natural health products and drug submissions to meet with regulatory agency requirements and ensure follow-up until approval. Furthermore, he/she will support quality related tasks. 

ESSENTIAL FUNCTIONS

Prepare, review, analyze and consolidate all relevant and related technical information required for the approval/licensing of products in Canada. 

Responsible for the timely completion of regulatory submissions and applications and related amendments. 

Accountable for assessing, coordinating and compiling deficiency responses in a timely manner. 

Collaborate with the Regulatory Team, Regulatory Officers as well as Operations Management to innovatively address regulatory issues and support achievement of Regulatory Compliance. 

Collaborate with Marketing and Global Regulatory Teams on a regular basis to assess and prioritize submissions to Health Canada. 

Implement new and proposed regulations and guidelines published by governmental regulatory authorities as they apply to the products. 

Ensure compliance with government regulations by providing Health Canada with all necessary technical information relating to changes or modifications to medical devices, natural health products, and Over-the-Counter (OTC) drug products. 

Manage and actively participate in InSight Corporate System and related regulatory databases for all products approved for sale in Canada to ensure accuracy of information and related change initiatives.

Ensure all regulatory activities involving the importing and distributing of medical devices, natural health products and OTC drugs are in compliance with their respective regulations. 

Ensure Technical Contract Agreements are maintained & respected based on the medical device regulations as an Importer and Distributor of medical devices.

Participate in Quality and Regulatory compliance initiatives including writing and/or revising Standard Operating Procedures.

Provide Customer Operations and Customer Service support for tenders and customer requests.

Ensure all regulatory records are properly and adequately maintained in accordance with regulatory requirements and internal processes.

Support or lead special Regulatory business projects and assignments as required.

• University degree (BSc).
• Minimum of 3 years relevant experience in Regulatory Affairs in the medical devices industry. 
• Excellent knowledge of the Food and Drugs Act and Regulations.
• Experience in the preparation and filing of medical devices and drugs submission.
• Detail oriented, accurate, and results driver.
• Must be bilingual.