Job Description

Company Overview

Quantimetrix, located in Redondo Beach, California, designs, develops, and manufactures clinical laboratory quality controls. For nearly 50 years, we have delivered industry-leading products and services to the medical community.

Quantimetrix is expanding its global footprint and seeking a dynamic Regulatory Affairs Specialist to drive international product registrations and ensure regulatory compliance across multiple markets. If you have a passion for global regulatory strategy and enjoy collaborating with cross-functional teams, this role is for you!

What You’ll Do

• Manage international product registrations from start to finish across multiple regions (EU, LATAM, APAC, Middle East)
• Serve as the primary regulatory contact for international distributors
• Prepare and submit registration dossiers, technical files, and supporting documentation
• Track submission timelines, monitor regulatory changes, and provide intelligence for market entry strategies
• Maintain regulatory documentation and support audits, inspections, and post-market compliance activities
• Partner with QA, Sales, Marketing, R&D, and internal teams to ensure seamless international market access

What We’re Looking For

• Education: Bachelors in Life Sciences, Regulatory Affairs, or related field (Master’s preferred)
• Experience: 5+ years in regulatory affairs for medical devices, IVD, or pharma with proven international registration success
• Knowledge of ISO 13485, IVDR , and global regulatory frameworks
• Experience supporting distributors and regulatory consultants
• Strong project management, communication, and organizational skills
• Fluency in English; additional languages (Spanish, Portuguese, French, German) a plus
• Preferred Certifications: RAC (International), CQA

Why Join Us

• Play a key role in global market expansion for innovative IVD products
• Opportunities to lead regulatory initiatives and impact strategic decisions

Additional Information

Compensation

The salary range for this position is $90,000 - $100,000 and will be determined based on experience, skills, education, certifications, and location

Benefits

• Medical, dental and vision benefits
• Life insurance
• 401K match
• FSA
• PTO
• Educational assistance program
• Employee Discounts provided through PEO
• Employee Assistance Program

Ready to make a global impact? Apply now and help us bring our products to patients worldwide!

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