Regulatory Affairs and Quality Manager

This role leads the regulatory and quality function for a Canadian medical device distribution business. The successful candidate will define the future operating model, strengthen day-to-day controls, and support the team with hands-on guidance when priority issues arise. You will be responsible for helping build a practical quality system suited to distribution and service activities, while also ensuring the business remains prepared for inspections and ongoing compliance requirements. Key responsibilities include overseeing Canadian regulatory obligations, maintaining required records, and supporting product compliance activities such as licensing, traceability, labelling, complaints, recalls, and supplier-related changes. You will also advise internal teams on regulatory considerations for new products, product updates, claims, and market introduction. On the quality side, you will lead the development and improvement of a quality management system, including document control, training, corrective actions, complaints handling, audits, change management, management review, and supplier oversight. The role also involves supporting practical controls across receiving, storage, service work, returns, and nonconforming products. In addition, you will manage and develop a small team, set clear priorities and escalation routes, and work closely with colleagues across operations, commercial, supply chain, service, finance, and leadership. Experience in a regulated industry, along with strong leadership and communication skills, is required.