Quality Assurance Regulatory Affairs Manager

7 days ago

Toronto, Ontario, Canada Salient Medical Solutions Full time

Regulatory & Quality Affairs Manager

Location: Vaughan, ON (On-Site)

Type: Full-Time

Salary Range: $80,000 - $110,000 (depending on experience level)

Experience: 3–5 Years Preferred

About Salient Medical Solutions

Salient Medical is a Canadian leader in the distribution of advanced medical technologies across three primary categories:

  • Ophthalmology: Including intraocular lenses, diagnostics, and surgical technologies.
  • Medical Aesthetics: Featuring energy-based devices, PRP systems, and injectables.
  • Skin Sciences: Offering products including sunscreens, natural health products (NHPs), DIN-registered topicals, and skincare regulated under Cosmetic Notification guidelines.

We partner with global innovators and support Canadian clinics, hospitals, and specialists with premium products and ongoing training.

Position Summary

Salient is seeking an experienced Regulatory & Quality Affairs Manager to oversee our regulatory strategy and lead all aspects of our quality management system. This in-office role at our Vaughan headquarters is ideal for a detail-oriented, proactive leader who is comfortable balancing day-to-day compliance with strategic oversight.

Key Responsibilities

  • Lead all regulatory affairs activities including Class II–IV medical device license submissions, renewals, and amendments with Health Canada
  • Manage ISO 13485:2016 MDSAP, MDEL, DEL and NHP certifications, including audits, CAPAs, internal audits, and documentation
  • Oversee the Quality Management System (QMS), ensuring compliance with Canadian and international standards
  • Maintain regulatory files for NHPs, DIN products, and cosmetics, including labeling and notifications
  • Collaborate cross-functionally with Sales, Product Management, Operations, and Executive teams to ensure regulatory and quality compliance across product lifecycles
  • Monitor evolving regulations and ensure organizational readiness and alignment

Qualifications

  • 3–5 years of experience in Regulatory and/or Quality Affairs (medical device experience in Canada strongly preferred)
  • Strong working knowledge of Health Canada medical device regulations (SOR/98-282), MDSAP, and ISO 13485
  • Experience managing QMS processes, document control, and audit readiness
  • Familiarity with Canadian regulatory requirements for NHPs, DINs, and cosmetics
  • Exceptional attention to detail, organization, and communication skills
  • Degree in science, engineering, or a health-related discipline preferred
  • Expertise in Greenlight Guru Quality Management System an asset

Why Join Salient?

  • Join a dynamic, growing company bringing cutting-edge medical technologies to Canada
  • Take ownership of a core function with high visibility and impact
  • Be part of a collaborative, agile team that values initiative, integrity, and innovation

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