Vice President, MedTech Cardiovascular Regulatory Affairs

Vice President of MedTech Cardiovascular Regulatory Affairs at IQVIA MCRA, leading regulatory strategy and submissions for medical device and diagnostics clients. The role involves department management, regulatory submission development, client relationships, and team leadership across multiple complex projects.

Responsibilities

• Manage and grow regulatory department including budgets, hiring, client relationships, and business development
• Develop and execute regulatory submissions including 510(k), IDE, PMA, IND, BLA, technical documentation, and regulatory strategies
• Lead complex regulatory projects as primary contact with clients and regulatory bodies
• Oversee regulatory affairs staff development, professional growth, and ensure timely project completion
• Collaborate across MCRA departments and executive management to guide regulatory department progress

Requirements

• Bachelor's degree in scientific, engineering, or regulatory discipline; Master's or PhD preferred
• Minimum 15 years regulatory affairs experience with medical devices, drugs, or biologics submissions
• Minimum 3-5 years managing people in regulatory affairs or biomedical R&D projects
• US and/or international regulatory experience and fluency with FDA, Notified Body, ISO 13485
• Domain expertise in cardiovascular or other therapeutic areas with clinical research and data analysis knowledge
• Strong written and verbal communication skills, including medical/technical writing and presentation abilities
• Demonstrated leadership managing multiple projects with competing deadlines and mentoring junior staff