Quality & Regulatory Coordinator

Trudell Healthcare Solutions; London; On-site; GBP 35,000 - 55,000; Full time

Job summary

A forward-thinking company is seeking a Quality & Regulatory Coordinator who is passionate about healthcare and quality assurance. This role involves ensuring compliance with quality systems, performing internal audits, and maintaining regulatory standards. The ideal candidate will thrive in a dynamic environment and contribute to continuous improvement initiatives. Join a reputable firm dedicated to enhancing patient care and making a meaningful impact in the healthcare industry. If you are detail-oriented and enjoy working in a collaborative setting, this opportunity is perfect for you.

Benefits

Paid Sick Days

3 weeks paid vacation

Health and Dental Benefits

Pension Plan

Life Insurance

Employee Assistance Plan

Disability Insurance

Employee Recognition for Milestone Anniversaries

Regular Salary Reviews

Encouraged Professional Development

Qualifications

• 3-5 years of Quality Assurance experience required.
• Post secondary diploma in Health Sciences or related discipline.
• Strong written and verbal communication skills.

Responsibilities

• Ensure compliance with quality systems and documentation.
• Perform internal audits and assist with external audits.
• Coordinate product recalls and regulatory submissions.

Skills

Quality Assurance

Regulatory Compliance

Document Control

Internal Audits

ISO 13485

Microsoft Office

Interpersonal Skills

Communication Skills

Education

Post secondary diploma in Health Sciences

Post graduate certificate in Quality Assurance

Documented ISO certificate/training

Job description

Quality & Regulatory Coordinator:

• 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!

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 for 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:

• Ensure proper documentation and resolution of product complaints.
• 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.
  
  

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 preventive corrective 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.
  
  

Skills & Qualifications:

Education and Experience:

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

Specialized Skill or Knowledge:

• Ability to work independently.
• Strong interpersonal skills.
• Excellent written and verbal communication skills.
• Intermediate experience in Microsoft Office applications.
• 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.
  
  

***

Since 1922, Trudell Healthcare Solutions Inc., a member of the Trudell Medical Group, has been a stable and financially sound Canadian-based employer, headquartered in London, Ontario. For over 90 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.

If you feel you meet the qualifications for this role, please submit your resume with the subject line “Quality & Regulatory Coordinator – THS” to Human Resources, at [e-mail].

We thank all applicants for their interest in joining our team. Only those to be interviewed will be contacted. For more information, visit us at www.trudellhs.com. Trudell Healthcare Solutions Inc. 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 accommodations during the recruitment process, please let us know.