About Our Client

Our client is a group of innovative healthcare companies specializing in the manufacturing, sales, and service of medical devices, with operations across North America. They provide advanced products and service solutions to healthcare providers in Canada and internationally. Their commitment lies in delivering top-quality products and services that not only comply with regulatory standards but consistently exceed customer expectations.

They are currently looking for a detail-driven and proactive Quality Assurance and Regulatory Affairs Specialist to join their team. This role is key to maintaining their high standards of quality and regulatory compliance across the group of companies. You will collaborate with QA/RA, Technical, and Operations teams to support and enhance their Quality Management Systems (QMS) in accordance with standards such as ISO 9001, ISO 13485, the Canadian Medical Device Regulations (SOR/98-282), and U.S. FDA CFR 820.

Key Responsibilities

• Perform document control tasks, including preparation, review, distribution, training, filing, and archiving of controlled documents.
• Support internal and external audits, including preparation, execution, and follow-up.
• Assist in investigating non-conformities through root cause analysis and reporting.
• Develop, implement, and monitor corrective, preventive, and continuous improvement actions.
• Help prepare and maintain regulatory submissions and compliance reports.
• Support licensing processes for medical devices and medical device establishments.
• Participate in supplier qualification and evaluation activities.
• Collaborate across departments to resolve quality and regulatory issues and support process improvements.
• Assist in post-market surveillance efforts, including tracking recalls, reviewing customer feedback, and managing complaints.
• Contribute to the development and maintenance of Occupational Health and Safety programs.
• Carry out additional tasks as assigned by the QA/RA Manager.

Qualifications & Skills

• Strong interpersonal and communication skills, with the ability to collaborate effectively across teams and with external partners.
• Ability to resolve regulatory and quality issues diplomatically and professionally.
• Minimum one year of experience in Quality Assurance and Regulatory Affairs preferred.
• Bachelor’s degree in a relevant discipline such as Health Sciences, Public Health, Biomedical Engineering, or Regulatory Affairs.
• Familiarity with regulatory frameworks such as ISO 9001, ISO 13485, MDSAP, ISO 14971, FDA CFR 820, and SOR/98-282 is an asset.
• Excellent organizational and analytical skills; capable of managing multiple priorities.
• Proficient in Microsoft Office Suite (Word, Excel, PowerPoint, Outlook).

Salary range $60 - $80K depending on experience. Medical and Dental, vacation, RRSP matching.