Medical affairs Jobs in Oakville, ON

Senior Manager, Quality & Regulatory Affairs

• Business Unit: Draeger Medical Canada, Inc., Job-ID: 1164
• Location: Mississauga
• Function: Quality
• Work Location: Hybrid
• Employment Type: Permanent

The Job Responsibilities

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.

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.

Your Qualifications

• 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

Compensation

The targeted base pay range for this role is $114,000–$136,800 CAD, depending on location, experience, skills, and other job‑related factors. This role is also eligible for an annual bonus.

Artificial Intelligence (AI) is not used to screen or select applicants.This posting is for an existing vacancy.

Dräger Benefits

At Draeger, Technology for Life means investing in the wellbeing of our people—both at work and at home. We offer a competitive benefits package designed to support your health, growth, and future, including:

• Comprehensive medical, dental, and vision coverage
• Paid vacation starting at 18 days per calendar year
• RRSP matching to help you plan for the future
• Tuition reimbursement for continued learning
• Wellness and employee support programs
• Life and other insurance options
• Corporate gym membership discounts

We’re committed to creating a workplace where you can thrive. Connect with your Draeger recruiter to learn more.

Who we are

Draeger has several sites located across North America as well as field-based sales and service positions. Our North America headquarters is located in Telford, PA just north of Philadelphia. We also have US sites in Andover, MA, and Houston, TX. Our Canada site is located in Mississauga, Ontario.Our field based Sales and Service workforce, located across Canada, is focused on building and strengthening long term relationships with our customers in the delivery of Draeger’s exceptional portfolio of Medical and Safety products and solutions.Draeger is an equal opportunity employer and is committed to a diverse workforce. All candidates are encouraged to apply regardless of race, ancestry, colour, ethnic origin or place of origin, citizenship, creed, sex, sexual orientation, gender identity, gender expression, age, record of offences (for which a pardon has been granted), disability, marital or family status, or any other prohibited ground under applicable provincial human rights legislation.

Interested?

Please, apply directly through our career portal.We look forward to receiving your application.