Vice President, MedTech Cardiovascular Regulatory Affairs

Responsibilities

• Manage and grow the cardiovascular regulatory department, including budgeting, hiring, and business development.
• Develop and execute regulatory strategies and submissions such as 510(k), IDE, PMA, IND, BLA, and STED.
• Lead regulatory affairs staff, facilitating professional development and ensuring project accuracy and timeliness.
• Act as the primary contact for client companies and regulatory bodies on complex projects.
• Drive business development functions to secure new clients and projects through thought leadership.
• Collaborate with internal departments including clinical, compliance, and quality assurance to guide company progress.

Requirements

• Bachelor’s degree in a scientific, engineering, or regulatory discipline (MS or PhD preferred).
• Minimum of 15 years of experience in Regulatory Affairs related to medical devices, drugs, or biologics.
• 3 to 5 years of experience in people management within regulatory affairs or biomedical R&D.
• Proven expertise with FDA, Notified Body, or ISO 13485 regulations.
• Strong medical and technical writing skills with the ability to communicate complex strategies.
• Extensive experience in project management and managing client relationships.
• Deep understanding of clinical research, data analysis, and pre-clinical testing design.

About the Company

IQVIA is a leading global provider of clinical research services, commercial insights, and healthcare intelligence to the life sciences and healthcare industries. As part of IQVIA MedTech, MCRA delivers integrated lifecycle solutions for the medical device and diagnostics industry, supporting innovation from concept to commercialization.