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About the Role

Trudell Healthcare Solutions is seeking a detail-oriented Quality & Regulatory Coordinator to ensure compliance with quality systems, maintain regulatory compliance, and support quality standards. This role is crucial for strengthening compliance and ensuring effective processes.

Responsibilities

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
Perform internal audits, assist with external audits and Health Canada inspections
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
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
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

Requirements

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

Skills

Strong organizational skills
Analytical thinking
Commitment to continuous improvement
Solutions-focused mindset
Independent thinking
Collaboration
Managing competing priorities
Demonstrated proficiency in Microsoft suite of products
Strong interpersonal skills
Excellent written and verbal communication skills
Intermediate experience in Microsoft suite of products

Location

London, Ontario

Work Type

Office/Warehouse setting
Overtime eligible

Experience Level

Three (3) to five (5) years of Quality Assurance experience

Education Level

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

Salary/Compensations

Fair and equitable compensation

Benefits

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

About the 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.
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.

Equal Opportunity

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.