Regulatory Affairs Project Manager

• Work with internal teams and Roche affiliates on innovative medical diagnostic products in APAC, LATAM, the Middle East, and Africa
• Identify process improvements and support implementation
• Assist with regulatory approval activities for in vitro diagnostic medical devices in global markets
• Support currently marketed products by reviewing engineering changes, labeling, product changes, and compliance documentation
• Maintain product technical files and perform ongoing compliance activities related to global directives and regulations
• Assist with submissions for a variety of device regulatory approvals
• Maintain current knowledge of applicable regulatory requirements and scientific/technical issues
• Interface with regulatory authorities on regulatory and technical matters as directed
• Provide regulatory support on project teams
• Assist in creating Global and Network Procedures and policy guidelines
• Review labeling changes, advertising, and promotional activities
• Serve as an internal regulatory consultant for on-market product issues
• Review proposed device changes
• Travel for business as required

• Bachelor's or Master's degree in Life Science, Data Science, or a related subject
• 5 years of experience in regulatory, development, clinical affairs, quality, or program management in IVD, medical device, or pharma industries
• Experience in Healthcare regulatory affairs
• Ability to manage high-complexity work and/or global projects, or equivalent experience
• Experience with international regulatory submissions including CE IVD, MD, IDE, 510(k), and PMA submissions is preferred
• Experience with Med Tech Regulatory Information Management System
• Experience working in a cross-functional team setting and cross-cultural setting is preferred
• Regulatory Affairs Certification preferred
• Some business travel as required

Demonstrates expertise in regulatory affairs for in vitro diagnostic medical devices, including international submissions and compliance with global regulations. Proven ability to manage complex projects and collaborate effectively in cross-functional and cross-cultural teams.

• Regulatory Affairs Certification
• International Regulatory Submissions
• In Vitro Diagnostic Medical Devices
• Healthcare Regulatory Affairs
• Med Tech Regulatory Information Management System

• Regulatory Approval Activities
• Compliance Documentation
• Technical File Maintenance
• Process Improvement
• Project Management

• Cross-Functional Team Collaboration
• Communication Skills

• Regulatory Affairs Certification

• Medical Device
• Pharma
• IVD
• Global Directives
• CE IVD
• MD
• IDE
• 510(k)
• PMA