Company Overview
Quantimetrix, located in Redondo Beach, California, is a family-owned company that 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
· Collaborate with a cross-functional, international team
· Opportunities to lead regulatory initiatives and impact strategic decisions
Compensation
The salary range for this position 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
Apply now and help us bring our products to patients worldwide! Send your resume to hr@quantimetrix.com.