Quality & Regulatory Coordinator

Are you passionate about maintaining high standards, navigating regulatory requirements, and ensuring quality is at the heart of everything you do? We at Trudell Healthcare Solutions are looking for a detail-oriented, proactive, Quality & Regulatory Coordinator who brings strong organizational skills, analytical thinking, and a commitment to continuous improvement. You'll take pride in accuracy, approach challenges with a solutions-focused mindset, and thrive in a role that requires both independent thinking and collaboration across teams. With a keen eye for detail and the ability to manage competing priorities, you'll play an important role in supporting our quality standards, strengthening compliance, and ensuring our processes remain consistent and effective. If you're someone who takes initiative, values accountability, and is passionate about doing things right, we'd love to hear from you!

Our Company: Trudell Healthcare Solutions Inc. is a Canadian, family-owned clinical and service-oriented distributor providing unique, innovative products to select segments of the Canadian healthcare market. With a skilled, knowledgeable and motivated team, the company is committed to exceeding our customers’ expectations in delivering cost effective solutions to improve patient outcomes.

The Position: Ensure compliance with the company’s quality system through document control, internal audits, licensing, complaints handling and product recall administration. Maintain regulatory compliance by providing accurate, relevant and timely information for internal & external resources.

What We Offer:
In addition to fair and equitable compensation and the excitement of working for a growing and reputable company, we offer:

• Challenging careers that provide the opportunity to learn constantly
• Clear, consistent, and demonstrated values
• A positive and motivating Corporate Culture
• Encouraged Professional Development
• Employee Recognition for Milestone Anniversaries
• Regular Performance Appraisals
• Regular Salary Reviews
• Paid Sick Days
• 3 weeks paid vacation to start
• Comprehensive Group Family Benefits including:

• • Health and Dental Benefits
  • Pension Plan
  • Life Insurance
  • Employee Assistance Plan
  • Disability Insurance
  • Out of Country Insurance Coverage

Key Responsibilities:

Quality Assurance

• Ensure proper documentation and resolution of product complaints
• Review quality control inspections and authorized releases of medical devices and natural health products
• Record QA non-conformances, assist in corrective action implementation, and ensure resolution/closure
• Assist operations to identify and resolve product safety and quality concerns

Quality Management

• Perform internal audits, assist with external audits and Health Canada inspections as required
• Coordinate improvement, implementation and maintenance of ISO 13485 procedures
• Coordinate improvement, implementation, and maintenance of Natural Health product procedures
• Identify & document required preventative corrective actions (CAPA), assist in implementation and complete verifications
• Participate in Risk Analysis and develop of Risk Management plans
• Review and maintain technical file for medical device licenses
• Contribute towards the continuous improvement of THS’ quality systems
  
  

Regulatory and Compliance

• Complete annual review of Health Canada (HC) Medical Device Licenses, HC Medical Device Establishment License, and Natural Health product site license
• Process the Medical Device Establishment License renewal(s)
• Participate in regulatory projects related to new product launch
• Coordinate product recalls; communicate with customers and suppliers; submit all required documents to Health Canada
• File mandatory reports with Health Canada
• Prepare, submit, and track regulatory submissions (incl. Summary Reports, Shortages)
• Provide support for regulatory submissions as required

Administration

• Maintain current body of knowledge on regulations and standards
• Ensure communication is effective and informative regarding issues which may affect the quality of service or products
• Prepare monthly and annual reports to indicate trends and summarize issues related to product complaints
• Ensure cooperation with special projects as required

As an ideal candidate, you have:

• Post secondary diploma in Health Sciences or related discipline
• Post graduate certificate in Quality Assurance is an asset
• Documented ISO certificate/training is an asset
• Demonstrated proficiency in Microsoft suite of products
• Three (3) to five (5) years of Quality Assurance experience
• Ability to work independently
• Strong interpersonal skills
• Excellent written and verbal communication skills
• Intermediate experience in Microsoft suite of products
• Bilingual both written and oral is an asset

Essential Duties:

• Fluent in English, both written and oral
• Ability to lift and/or move up to 50lbs (23kg)

Working Conditions:

• Office/Warehouse setting
• Frequent interruptions
• Occasional domestic and/or international travel

• Compensation based on a regular work week of thirty-seven and one half (37.5) working hours, with additional working hours as required to meet ongoing business demands and to fulfill job responsibilities
• Overtime eligible

Since 1922, Trudell Medical Marketing Limited, a member of the Trudell Medical Group, has been a stable and financially sound Canadian-based employer, headquartered in London, Ontario. For over 100 years, we have enjoyed the reputation of being successful and trustworthy in the eyes of our customers, our suppliers and our staff. We are passionate about selling, servicing and distributing technologically advanced Critical Care and Respiratory products and state-of-the-art Operating Room products to hospitals across Canada.

We thank all applicants for their interest in joining our team. Only those to be interviewed will be contacted.

Trudell Healthcare Solutions is committed to providing fair and equitable compensation opportunities to all teammates. The range displayed on each job posting reflects the target for new hire salaries for the advertised position. Within the range, individual compensation is determined by job-related skills and knowledge, relevant professional, lived experience, and/or work location. Our compensation policies and practices are designed to allow our colleagues’ growth and salary progression as they develop in their role. As a candidate, you are encouraged to ask compensation-related questions and have an open dialogue with your recruiter, who can provide specific details for this role and share more information about our total rewards package.

As part of our recruitment process, we may use AI tools to screen applicants and assist in evaluating candidate qualifications. All final hiring decisions are made by our recruitment team.

Trudell Healthcare Solutions is an equal opportunity employer it is important to our Company that all its employees, including those with disabilities, find our workplace to be welcoming and supportive. If you are a candidate with a disability who requires accommodation during the recruitment process, please let us know.