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Drägerwerk AG & Co. KGaA•Mississauga, ON

32d•CA$114,000 - CA$136,800•Hybrid

About The Position

Drager is hiring a Senior Manager, Quality & Regulatory Affairs (Sales & Service) to work hybrid out of our Mississauga, Ontario office. We are seeking an experienced Senior Manager, Quality and Regulatory Affairs to join our team in Mississauga. In this role, you will lead the implementation and continual improvement of Draeger’s integrated management systems and ensure compliance with all applicable certifications, regulations, and standards for our Canadian sales and service operations. You will drive quality excellence, regulatory adherence, and operational effectiveness across the organization.

Requirements

University degree in business, engineering, or related field
5–7 years of relevant work experience
Minimum 5 years in quality and regulatory affairs management within the medical device sector
Project management experience
Current quality management qualifications
Up‑to‑date knowledge of relevant international and local standards
Strong influencing and leadership skills

Responsibilities

Develop, implement, and maintain processes that support integrated management system objectives and demonstrate compliance with relevant regulatory, occupational health and safety, environmental, and legislative requirements.
Review and interpret regulatory rules related to company products and processes; establish quality system procedures to ensure compliance with local regulations and global processes.
Collaborate with management, process owners, and colleagues to create and maintain quality system documentation including policies, procedures, work instructions, and forms.
Ensure appropriate training on quality and regulatory topics while providing expert guidance to support compliant operations.
Act as liaison with manufacturers to integrate national regulatory and customer requirements into product design and development processes.
Maintain fault signaling and improvement systems, including incident reporting, complaint handling, CAPA, risk notifications, and product summary reporting.
Conduct data analysis and act as Management Representative, reporting performance metrics to authorities and internal leadership.
Establish strategies for recalls, advisory notices, complaint handling, and quality planning.
Lead management reviews, define quality metrics, and ensure effective controls for non‑conforming product handling and disposition.
Develop and maintain an internal audit program; plan and support external audits. Ensure timely closure of audit findings through root cause analysis and corrective actions.
Serve as primary interface for customers, regulators, and manufacturers regarding recalls, advisory notices, incident investigations, and complaint management.
Lead, coach, and evaluate team members, setting clear performance standards and ensuring objectives are met.
Collaborate with regional and global regulatory teams on local product registrations and approvals; participate in meetings with authorities and technical committees as appropriate.
Act as Management Representative for ISO 9001, ISO 13485, ISO 14001, and ISO 45001.
Perform additional duties as assigned.