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Regulatory Affairs Lead

Company

Norgen Biotek Corp

Location

thorold, niagara region

Posted

July 20, 2026

Position Overview

Job Overview

  • Location: 3430 Schmon Pkwy, Thorold ON
  • Department: Regulatory
  • Pay: $60,000–$70,000 CAD per year
  • Job Type: Full-Time, On-Site
  • Work Hours: Monday to Friday, 8:30am to 5:00pm

Benefits

  • Dental care
  • RRSP match
  • Extended health care
  • On-site parking

Responsibilities

  • Lead the preparation, coordination, and compilation of documents for regulatory submission to Health Canada, The FDA, ISO and CE marking.
  • Apply for and maintain approvals and certifications from various Regulatory bodies.
  • Maintain knowledge on regulations, policies, and guidance documents for medical devices for Health Canada, The Food and Drug Administration, and the European Union for CE marking.
  • Maintain knowledge of Norgen Biotek products and identify potential regulatory submission pathways an...

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