Director, Regulatory Affairs - Trividia Health : Job Details

About Us At Trividia Health, we are committed to improving lives through innovative diagnostic solutions. As a leader in the medical device and in vitro diagnostics (IVD) industry, we strive for excellence in regulatory compliance, quality, and customer satisfaction. We are currently seeking an experienced and driven Director of Regulatory Affairs to lead our regulatory efforts across global markets. Position Summary The Director, Regulatory Affairs is responsible for all aspects of regulatory strategy and compliance, including U.S. FDA and international product registrations. This role oversees regulatory submissions, vigilance reporting, and labeling compliance, and ensures ongoing adherence to applicable global medical device regulations. The Director also serves as the company's representative to key regulatory bodies and will manage a team responsible for Regulatory Affairs and Customer Care functions. Key Responsibilities • Lead U.S. regulatory submissions, including 510(k)s, CLIA waivers, and FDA correspondence. • Develop and execute global regulatory strategies for new and existing IVD products. • Manage international product registrations and licensing across key markets including the EU, UK, Canada, Mexico, Brazil, Australia, and Japan. • Serve as the European Person Responsible for Regulatory Compliance (PRRC). • Ensure product labeling and marketing claims meet all regulatory requirements. • Maintain product technical files and declarations of conformity. • Lead Medical Device Reporting (MDR) and global vigilance reporting activities. • Provide regulatory guidance and strategic advice to internal stakeholders and business partners. • Collaborate with Sinocare and affiliated companies on joint regulatory initiatives. • Represent the company during audits and inspections from FDA, ISO registrars, and Notified Bodies. • Manage and oversee end-user complaint handling operations through the Customer Care team. • Ensure ongoing compliance with training, workplace safety, and regulatory updates. Supervisory Responsibilities • Lead and develop the Regulatory Affairs and Customer Care teams. • Responsible for hiring, training, performance management, and team development. • Drive a culture of quality, accountability, and continuous improvement. Qualifications • Bachelor's degree in Chemistry, Biology, Medical Technology, Engineering, or related scientific discipline. • A minimum of 15 years' experience in regulatory affairs, preferably in the IVD or medical device industry. • Strong working knowledge of U.S. FDA, EU MDR, and other global regulatory frameworks. • Experience with clinical laboratory settings is highly desirable. • Regulatory Affairs Certification (RAC) preferred. • Demonstrated leadership experience, strategic thinking, and cross-functional collaboration. • Exceptional communication, organizational, and decision-making skills. Additional Information • This is a full-time, on-site role. Trividia Health uses E-Verify to confirm the employment eligibility of all newly hired employees. To learn more about E-Verify, including your rights and responsibilities, please visit www.dhs.gov/E-Verify EQUAL OPPORTUNITY EMPLOYER: Trividia Health, Inc. is an Equal Opportunity, Affirmative Action, E-Verify employer. Employment decisions for all applicants and employees will be made without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, age, national origin, marital status, veteran status, disability, or other characteristics protected under local, state or federal law.