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Trividia Health, Inc. · 1 day ago

Director, Regulatory Affairs

Fort Lauderdale, FL, US

Full-time

Onsite

Director/Executive

15+ years exp

Trividia Health, Inc. is committed to improving lives through innovative diagnostic solutions, and they are seeking an experienced Director of Regulatory Affairs to lead their regulatory efforts across global markets. This role is responsible for regulatory strategy and compliance, overseeing submissions, vigilance reporting, and ensuring adherence to global medical device regulations.

Health CareHealth DiagnosticsManufacturingMedical

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

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

Qualification

Regulatory AffairsU.S. FDA knowledgeGlobal regulatory frameworksRegulatory Affairs CertificationLeadership experienceClinical laboratory experienceStrategic thinkingCross-functional collaborationCommunication skillsOrganizational skillsDecision-making skills