Regulatory Affairs & Quality Manager

The Company is part of the Diploma Healthcare Group (DHG) which is a group of specialized medical device distribution companies operating in Canada, Australia, New Zealand and Ireland Somagen Diagnostics Inc. was founded +30 years ago in Edmonton and has grown steadily to become Canada’s largest independent provider of medical diagnostic technology to laboratories, hospitals and clinics. Somagen is the exclusive Canadian distributor for many of the world’s most respected diagnostic product suppliers such as Polymedco, Phadia, and Sakura. We pride ourselves on being a highly technical sales organization providing leading support solutions to our clinical customers. Our proven business model has consistently achieved sustained growth even through challenging economic times. Vantage Endoscopy and AMT Surgical are leading sales focused distribution organizations specializing in high tech niche diagnostic and therapeutic medical products focused on Endoscopy/GI Suite, GI Clinics and Hospital Operating Rooms across Canada. What you’ll do: Lead and advance the Regulatory Affairs and Quality function across the Canadian business. This role combines three expectations: set the roadmap for the next phase of capability, develop the systems and team required to deliver it, and remain close enough to the work to support critical daily activities when needed. The Manager will lead the Regulatory Business Leads, strengthening regulatory control, and guide the design, implementation, and continuous improvement of a fit-for-purpose Quality Management System (QMS) for a distribution and service environment. This role is responsible for a variety of functions that include, but are not limited to: A. Regulatory Affairs and Canadian Market Compliance Own MDEL governance, Health Canada compliance, inspection readiness, and regulatory records. Ensure products distributed in Canada meet applicable licensing, traceability, labelling, and documentation requirements. Lead regulatory support for complaints, recalls, field actions, supplier changes, and Health Canada interactions. Advise business teams on regulatory requirements for new products, changes, claims, and market release. B. Quality Management System and ISO Readiness Lead development and implementation of an integrated QMS and roadmap toward ISO certification. Establish effective controls for documents, training, CAPA, complaints, supplier quality, change control, audits, and management review. Embed practical quality controls across receiving, storage, traceability, servicing, returns, and nonconforming product. Develop risk-based quality metrics, supplier oversight, and continuous improvement practices. C. People Leadership and Department Capability Lead and develop the Regulatory Specialist and Quality Lead, with clear responsibilities, priorities, and development plans. Build the future Regulatory and Quality operating model, including resources, external support, systems, and capacity. Establish efficient processes, escalation pathways, service expectations, and backup coverage. Provide hands-on leadership during inspections, recalls, audits, CAPAs, and other high-risk issues. D. Stakeholder Communication and Cross-functional Influence Partner effectively with Operations, Commercial, Supply Chain, Service, Finance, IT, and senior leadership. Maintain strong relationships with Health Canada, auditors, certification bodies, manufacturers, suppliers, and consultants. Translate complex regulatory and quality requirements into clear business guidance, risks, decisions, and actions. Influence cross-functional decisions while balancing compliance, customer needs, and operational priorities. Requirements: The successful individual will possess the following skills and qualifications: Progressive experience in Regulatory Affairs and Quality within medical devices, healthcare, or another regulated environment, including leadership responsibility. Demonstrated knowledge of Health Canada Medical Devices Regulations and practical experience supporting an importer or distributor operating under an MDEL. Experience designing, implementing, improving, or preparing a QMS for certification, preferably ISO 9001 and/or ISO 13485 in a distribution or service context. Hands-on experience with several core quality processes such as document control, training, change control, nonconformance, CAPA, complaints, recalls, supplier quality, audits, and management review. Proven people leadership, project leadership, and ability to move between long-term roadmap development and detailed execution. Exceptional written and verbal communication, with the judgment to engage effectively with regulators, auditors, suppliers, executives, functional leaders, and front-line teams. Strong analytical, organizational, and risk-based decision-making skills; able to manage competing priorities and maintain disciplined follow-through. What’s in it for you: Diverse and dynamic teams with challenging and exciting work An opportunity to have a real impact on our business. A great range of social activities Employee referral program And so much more!! Hours and Locations: Flexible 7.5-hour shift within office hours 8:00 AM – 5:00 PM. Mississauga (Meadowvale area) Hybrid work model Health & Safety Responsibilities: The successful candidate is expected to support and comply with all workplace health and safety requirements, including: Maintaining safe systems of work for manual handling, vehicle movements, storage, and equipment use (if applicable). Reporting incidents, near misses, and unsafe conditions and assisting with investigations. Follow site rules, safe working procedures, and use PPE as required. Maintaining safe systems of work for manual handling, vehicle movements, storage, and equipment use. Ensuring workplace inspections are carried out and hazards are promptly addressed (if applicable). Ensuring staff follow site rules, safe working procedures, and use PPE as required. Reporting incidents, near misses, and unsafe conditions and assisting with investigations. Monitoring compliance, investigating incidents, and ensuring corrective actions are completed within your area (if applicable). Note: The successful candidate must be eligible to work in Canada and will be subject to a background check and references. This job posting is a new vacancy Salary Range: $105,000 - $130,000 We rely on people, not algorithms. Our recruiters personally review every application no AI screening is used at any stage. In accordance with the Accessibility for Ontarians with Disabilities Act (AODA) 2005, should you require any accommodation during the recruitment process, please indicate this on your application and we will gladly work with you to meet your accessibility needs. If you are interested in working for a progressive and dynamic company with solid growth potential, in a field that has a direct impact on the lives of our employees, hospital staff and patients, we would like to hear from you on how you can contribute and grow with us!

Lead the Regulatory Affairs and Quality functions to ensure Health Canada compliance and MDEL governance for medical device distribution. Develop and implement an integrated Quality Management System (QMS) while leading a team of regulatory and quality specialists.

Requires progressive experience in Regulatory Affairs and Quality within the medical device industry, specifically with Health Canada regulations and ISO certifications. Must demonstrate strong people leadership skills and the ability to manage complex quality processes like CAPA and audits.

• Diverse and dynamic teams • Employee referral program • Social activities

• People leadershipSouhaitée

Relevées dans la description du poste. Confirmez les exigences importantes ci-dessus.

• Regulatory Affairs
• Quality Management Systems
• Health Canada Compliance
• MDEL Governance
• ISO 13485
• ISO 9001
• CAPA
• Risk-based Decision Making
• People Leadership
• Audit Management
• Complaint Handling
• Supplier Quality
• Change Control
• Stakeholder Communication
• Project Leadership
• Medical Device Regulations

• Healthcare
• Management & Leadership
• Manufacturing
• Legal
• Logistics

Expérience minimale

5+ ans

Postuler avant le

27 sept. 2026

Langue de l’offre

anglais

Heures de travail

38 heures par semaine

Niveau d’expérience

Mid-Senior level

Mode de candidature

La candidature directe est offerte