Vice President, MedTech Cardiovascular Regulatory Affairs

IQVIA · Washington, DC

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RegulatoryFull-time$169k–$472kCompany career page

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Role summary

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.

What they're looking for

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

What you'll be doing

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

Key requirements

Therapeutic area: Cardiovascular

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Date posted16 days ago

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