Senior Regulatory Lead

Bachelor’s degree in a related field or an equivalent combination of education and experience. Minimum of three years’ experience working in regulatory affairs function of distributor or medical device manufacturer of Software as Medical Device (SaMD) products and solutions. Documented experience achieving market approval for software medical devices in US, Canada, UK, and European markets. Strong working knowledge of Canada Medical Device Regulations SOR/980282; 21 C.F.R. 800; UK MDR; EU MDR. Knowledge of ISO 13485, ISO 14971, IS) 62304. Excellent written and verbal communication skills. Ability to work in a fast-paced environment. Ability to work with various data management tools (Excel, SharePoint, Atlassian/Jira, etc.)

Leads regulatory compliance activities for all medical device products. Manages medical device establishment registration and product licensing. Prepare and coordinate content of all pre-market regulatory submissions. Review product labelling for compliance. Establish and maintain relationships with authorized representatives. Manages change control process including regulatory classification and notifications. Support Complaint Handling Unit. Remains up to date on applicable regulation and standards. Work with Product, Service, and Quality to submit post-market surveillance plans and reports. Provide regulatory support during third-party audits of the QMS. Train teams on relevant FDA, Health Canada, and EU regulations and guidance.