Regulatory Affairs Manager

Description VHC REGULATORY AFFAIRS MANAGER Company: VahatiCor Status: Full-time, Exempt Location: Remote Reports to: Chief Human Resources Officer ABOUT THE COMPANY VahatiCor is a venture-backed medical technology company developing a new cardiovascular therapy. As the company grows beyond its startup incubator, it is building the regulatory systems and infrastructure needed to support its next stage. POSITION OVERVIEW The Regulatory Affairs Manager will develop and maintain regulatory strategies and manage submission activities for VahatiCor’s cardiovascular device programs. This person will prepare and coordinate regulatory filings, maintain regulatory records, and serve as a primary point of coordination with regulatory agencies and external regulatory specialists. This is a hands-on role with particular emphasis on investigational clinical programs and preparation for Premarket Approval (PMA). The manager will collaborate with R&D, Clinical, Quality, and Manufacturing to ensure that development activities, clinical evidence, and supporting documentation address regulatory requirements and submission objectives. The successful candidate will bring strong technical writing, careful attention to detail, sound judgment, and a collaborative, service-oriented approach to a growing medical device company. KEY RESPONSIBILITIES Regulatory Strategy and Planning - Develop and maintain US and international regulatory strategies aligned with VahatiCor’s product development, clinical study, and commercialization objectives. - Work with leadership and external regulatory specialists to establish appropriate submission pathways, required evidence, filing plans, and agency interactions. - Translate regulatory requirements into practical plans, including deliverables, responsibilities, timelines, and dependencies. - Identify gaps in technical and clinical documentation and coordinate actions to address them before submission. - Evaluate regulatory issues affecting product approvals and recommend actions that support company objectives. - Maintain current knowledge of FDA, European, and other applicable regulatory requirements, policies, and guidance. FDA Submissions and PMA Management - Prepare and coordinate FDA submissions, including Investigational Device Exemption (IDE) applications and amendments, PMA applications and related submissions, clinical progress reports, and other required filings. - Manage PMA preparation activities, including submission planning, content development, contributor coordination, document review, and assembly of the application. - Coordinate technical, preclinical, clinical, manufacturing, and quality information required for regulatory submissions. - Review submission documentation for accuracy, completeness, consistency, and alignment with supporting evidence. - Establish submission schedules and track document completion, internal reviews, approvals, and outstanding issues. - Coordinate responses to agency questions and requests for additional information, ensuring that responses address the questions raised and include appropriate supporting documentation. - Track submission status, response deadlines, approval conditions, and regulatory commitments. Clinical Study Regulatory Activities - Collaborate with Clinical Affairs on regulatory requirements supporting investigational device studies in the United States and applicable international markets. - Prepare and coordinate clinical study regulatory submissions, amendments, progress reports, and required safety reporting in collaboration with the responsible teams. - Coordinate regulatory reporting of unanticipated adverse device effects and other reportable events, as applicable. - Review study documentation for consistency with regulatory authorizations, device information, and agency commitments. - Track reporting obligations and approval conditions associated with clinical investigations. - Coordinate regulatory activities needed to support US and European study sites. Regulatory Agency and External Partner Coordination - Serve as a key company regulatory contact for US activities, working within established company approvals. - Develop and maintain productive relationships with regulatory agencies, external regulatory specialists, industry groups, and business partners. - Coordinate preparation for agency meetings, including meeting requests, briefing materials, questions, and supporting documentation. - Document agency feedback and translate resulting commitments into assigned actions and follow-up activities. - Coordinate reports and documentation for the European Authorized Representative, as applicable. - Manage assigned consultant deliverables, timelines, document reviews, and follow-up activities. Product Development and Regulatory Review - Provide regulatory guidance to cross-functional project teams during product planning, development, clinical evaluation, and preparation for commercialization. - Collaborate with R&D and Quality to ensure that development documentation and verification and validation evidence support submission requirements. - Assess the regulatory implications of proposed changes to device design, materials, manufacturing processes, labeling, or intended use. - Coordinate documentation of change assessments and determine whether additional evidence or regulatory filings are required. - Review labeling and other assigned product materials for consistency with intended use, supporting evidence, and regulatory authorizations. - Collaborate with commercial and business development colleagues, as applicable, on regulatory considerations affecting product planning and launch. Regulatory Records and Compliance - Maintain complete, organized regulatory submission files, agency correspondence, approvals, meeting records, and reporting documentation. - Ensure regulatory documentation, recordkeeping, and reporting are maintained to