Regulatory Affairs Specialist

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 Medical, dental and vision benefits 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 View email address on click.appcast.io. #J-18808-Ljbffr Quantimetrix