Regulatory Affairs jobs in United States

Job Title: Director /VP, Compliance

Location: Greater Vancouver, BC
Industry: In Vitro Diagnostics (IVD) / Medical Technology
Type: Full-Time | On-site
Reports To: Executive Leadership
Salary Range: $130,000 - $155,000 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, TGA)

• 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 ccampbell@talentsphere.ca. To apply, please use the TalentSphere job board.

TSSHP LI-TS1
LI-TS1
Job Posting ID: #16671166

Thank you for your interest in this job posting.

We look forward to hearing from you.

TalentSphere Staffing Solutions
talentsphere.ca

Canada

United States