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Job Location drjobs

Richmond - Canada

Yearly Salary drjobs

$ 130000 - 150000

Vacancy

1 Vacancy

Job Description

Job Title: Director Quality Assurance & Regulatory Compliance

Location: Greater Vancouver BC
Industry: In Vitro Diagnostics (IVD) / Medical Technology
Type: Full-Time On-site
Reports To: Executive Leadership
Salary Range: $130000 - $150000 per annum

About the Company:

Our client is a well-established and expanding MedTech company specializing in innovative IVD solutions that advance diagnostic accuracy and patient outcomes. Headquartered in Greater Vancouver the company is recognized for its dynamic culture cutting-edge product pipeline and commitment to global quality and regulatory excellence.

Position Overview:
Our client is an established and expanding MedTech company specializing in rapid diagnostic solutions that support global health. With a growing international footprint and an innovative pipeline the company is committed to delivering high-quality regulatory-compliant products that improve patient outcomes. This newly created leadership role will drive global compliance strategies oversee regulatory submissions and clinical operations and strengthen internal systems to support continued growth and international market access.

Key Responsibilities:

  • Lead global regulatory quality and clinical compliance strategy across the organization

  • Oversee regulatory submissions and act as liaison with international health authorities (e.g. Health Canada FDA EU)

  • Manage clinical studies and CRO relationships

  • Ensure QMS compliance with ISO 13485 MDSAP and other global standards

  • Align compliance activities with commercial operational and R&D teams

  • Monitor and interpret evolving regulatory requirements updating policies and processes as needed

  • Build and mentor a high-performing Quality Regulatory and Clinical team

Qualifications:

  • MSc in a relevant scientific or engineering field or equivalent combination of education and experience

  • 8 years experience in Quality Assurance Regulatory Affairs or Clinical Compliance ideally in IVD or medical devices

  • Proven expertise in international submissions (e.g. FDA Health Canada EU IVDR)

  • Hands-on leadership in QMS under ISO 13485 and MDSAP

  • Strong cross-functional collaboration and team-building skills

  • Experience overseeing clinical trials or CROs is a strong asset

Why Join:
This is an opportunity to make a meaningful impact in a company poised for growth with a leadership team that values innovation integrity and quality. Join a mission-driven organization where your expertise in compliance will help shape the future of diagnostic healthcare.

To Apply:
For a full job description contact Carla Campbell Executive Talent Consultant TalentSphere Life Sciences at . To apply please use the TalentSphere job board.

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Required Experience:

Director

Employment Type

Full-Time

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