Request a Quote
Contact Us

Regulatory & Quality Coordinator

Full time, Permanent

This is an in-office position located in Lachine, Quebec. 37.5 hours a week, Monday to Friday. Flexible hours.

 

Apply Now

Surgmed Group is seeking a dedicated and detail-oriented Quality Coordinator to support our Regulatory & Quality Manager in maintaining and improving our quality and regulatory systems. This role is crucial in ensuring compliance with industry standards and supporting the overall quality management objectives.

What You’ll Be Responsible For

  • Legalize documentation required by customers for international sales.
  • Respond to customer product and regulatory inquiries, collaborating with the Regulatory & Quality Manager to complete quality agreements.
  • Assist in audit preparation and support audit requirements as directed by the President and/or Regulatory & Quality Manager.
  • Update technical files with supplier information or company changes, including testing, forms, literature, labels, and IFUs (Instructions for Use).
  • Coordinate, compile, and maintain data for quality management objectives.
  • Perform general regulatory duties, including product review, classification, and other related tasks.
  • Support corrective and preventive actions, particularly those arising from audits.
  • Handle administrative tasks related to technical files, quality manuals, and production requests.
  • Monitor and approve production/inspection reports for sterile products and production summary records.
  • Approve new labels, modifications, or deletions of labels and IFUs.
  • Assist with FDA registration review and perform all required UDI (Unique Device Identification) registrations.

What You’ll Bring to the Team

  • Fluent in English, both written and spoken; French comprehension is an asset.
  • Experience and training in ISO 13485 with knowledge of ISO functionality and standards.
  • Detail-oriented with strong organizational and time management skills.
  • Experienced in Microsoft Office, particularly Excel and Outlook.
  • Comfortable with medical terminology and research-driven tasks.
  • Excellent interpersonal, verbal, and written communication skills.
  • Demonstrates initiative, good judgment, and a positive attitude.
  • Strong typing skills.
  • Minimum of 2 years of relevant experience.

Why You’ll Love Working Here

  • Dental care
  • Vision care
  • Disability insurance
  • Extended health care
  • Life insurance
  • RRSP match
  • Free snacks

Additional Information

This is an in-office position located in Lachine, Quebec. 37.5 hours a week, Monday to Friday. Flexible hours.

Apply Now
surgmed-logo__footer-white.png
Start typing to see content you are looking for.