Regulatory Affairs Manager

**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.