Quality & Regulatory Coordinator
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Key details
- Location
- London, ON, Canada
- Work style
- Onsite
- Level
- Mid level
- Experience
- 3–5 yrs
- Function
- Legal & Compliance
- Focus area
- other
- Posted
- 21h ago
Skills
capadocument controlinternal auditiso 13485microsoft officequality assurancequality controlquality managementrisk analysis
About the role
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
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