Director of Regulatory Consulting

Job Summary

To develop actionable business solutions for clients, the full-time remote Director of Regulatory Consulting will apply extensive expertise in regulatory affairs, oversee submissions for in vitro diagnostics, and generate new business through strategic partnerships and workshops.

Key responsibilities

• Direct the preparation of regulatory submissions and documentation for global clearance of in vitro diagnostics
• Design strategic approaches for regulatory approvals and collaborate with external experts to support research and development
• Generate new business through networking and assist in client proposals and presentations regarding regulatory strategies

Required qualifications

• Bachelor's degree in Life Sciences or equivalent work experience
• Minimum 5 years of applicable consulting experience focused on regulatory affairs
• At least 7 years of experience in a medical device or pharmaceutical consulting environment
• Direct experience in designing global regulatory and commercialization strategies
• Experience managing staff members and project teams