Director, Compliance

TalentSphere Staffing Solutions; Richmond; On-site; CAD 130,000 - 150,000; Full time

Job summary

A leading MedTech company in the In Vitro Diagnostics industry seeks a Director of Quality Assurance & Regulatory Compliance. This strategic position oversees quality management systems and ensures compliance with international regulations. Ideal candidates possess an MSc and significant experience in regulatory affairs, contributing to innovative health solutions.

Benefits

Dynamic culture

Commitment to quality excellence

Opportunity for growth and impact

Qualifications

• 8 years experience in Quality Assurance, Regulatory Affairs, or Clinical Compliance.
• Proven expertise in international submissions.
• Experience overseeing clinical trials or CROs is a strong asset.

Responsibilities

• Lead global regulatory quality and clinical compliance strategy.
• Oversee regulatory submissions and manage clinical studies.
• Ensure QMS compliance with ISO 13485 and MDSAP.

Skills

Leadership

Collaboration

Compliance Strategy

Education

MSc in relevant scientific or engineering field

Tools

ISO 13485

Job description

Job Title : Director Quality Assurance & Regulatory Compliance

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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Job Posting ID : #

Thank you for your interest in this job posting.

We look forward to hearing from you.

TalentSphere Staffing Solutions

Canada

Calgary : 403.910.9222

Edmonton : 587.333.7929

Kelowna : 250.448.8880

Montreal : 438.448.4300

Victoria : 250.294.8095

United States

USA Toll-Free : 1855.900.3435

469.498.2002

213.290.4030

Required Experience :

Director

Key Skills

Employment Type : Full-Time

Experience : years

Vacancy : 1

Yearly Salary Salary : 130000 - 150000

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