Associate Regulatory Affairs Director, Spine

Responsibilities

• Develop and execute regulatory services for client companies, including regulatory strategy, analysis, and development
• Manage the preparation of regulatory submissions such as 510(k), IDE, PMA, IND, BLA, Technical Documentation, STED, and CERs
• Design, review, and implement pre-clinical testing strategies
• Provide project leadership and maintain direct relationships with client companies and regulatory bodies
• Manage, mentor, and train junior members of the regulatory department
• Perform business development functions to secure new clients and projects
• Collaborate with internal departments including clinical, RHEMA, and quality assurance

Requirements

• Bachelor's degree in a scientific, engineering, or regulatory discipline (MS or PhD preferred)
• Minimum seven years of Regulatory Affairs experience related to medical devices, drugs, or biologics
• Proven experience managing regulatory submissions
• Deep knowledge of FDA, Notified Body, and ISO 13485 regulations
• Strong medical and technical writing skills
• Understanding of clinical research and data analysis
• Ability to lead multiple projects independently and manage client relationships professionally

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. Through MCRA, part of IQVIA MedTech, we deliver integrated lifecycle solutions for the medical device and diagnostics industry, supporting innovation from concept to commercialization.