Regulatory Affairs Specialist

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 dynamicRegulatory Affairs Specialistto 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 Youll 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 Were Looking For Education:Bachelors in Life Sciences, Regulatory Affairs, or related field (Masters preferred) Experience:5+ years in regulatory affairs for medical devices, IVD, or pharma with proven international registration success Knowledge ofISO 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!