Quality & Regulatory Coordinator (Ft)

Do you have an interest in the Healthcare industry and have a passion for helping people?

Do you consider yourself to be very organized, highly focused on details, and place a high importance on quality?

Do you consider yourself to be technically inclined and are able to think outside the box to resolve issues?

We at Trudell Healthcare Solutions “(THS)” are looking for an individual who is driven and shares our passion for customer excellence to contribute to the care patients receive while at the hospital, ultimately helping to improve their quality of life. If you have an interest in Quality Assurance and have responded yes to the above questions, THS currently has an exciting opportunity for you as a
**Quality & Regulatory Coordinator**

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**The Position**:Ensures 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 fo internal & external resources. Provide support for regulatory submissions as required. Contribute towards the continuous improvement of THS’ quality systems.

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

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**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 corrective/preventive actions (CAPA), assist in implementation and complete verifications.
- Participate in Risk Analysis and development of Risk Management plans for medical devices licensed by THS.
- Review and maintain technical file for medical devices licensed by THS.

**Regulatory & 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 under THS brand.
- 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)

**Administration**
- Support and provide back-up for Quality Assurance Technician 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.

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**Skills & Qualifications**:
**Education and Experience**
- Post secondary education in Health Sciences or related discipline.
- Post graduate certificate in Quality Assurance is preferred.
- Documented ISO certificate/training is preferred.
- Minimum three to five (3-5) years of Quality Assurance experience is required.

**Specialized Skill or Knowledge**
- Ability to work independently.
- Strong interpersonal skills.
- Excellent written and verbal communication skills.
- Bilingual both written and oral is an asset.

**Essential Duties**
- Ability to communicate and handle quality and regulatory issues.
- Ability to travel occasionally.
- Ability to lift and/or move up to 50lbs (23kg).

**Working Conditions**
- Office/ Warehouse setting within our facility in London, ON.
- Frequent interruptions.
- 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 full fill job responsibilities.

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- Since 1922, Trudell Healthcare Solutio